GlaxoSmithKline

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: DELETE FROM cache_filter WHERE expire != 0 AND expire <= 1283571509 in /persistent/html/includes/cache.inc on line 23.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:ef294d0b652bc76dcc67492f1976e9e2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f40437d952d6f3bdfd5529d6882eee40' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:f40437d952d6f3bdfd5529d6882eee40' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Proportion of subjects with vaccine take [&nbsp;Time&nbsp;Frame:&nbsp;Two months after the second dose&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:3f0e3279091ecc6eacea31b66d0722e3' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence of any grade 2 or 3 fever, vomiting or diarrhea [&nbsp;Time&nbsp;Frame:&nbsp;Within the 15-day solicited follow-up period after any dose of study vaccine.&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:86c45f7be839764b0dd1dadbf3215c3c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence of each type of solicited symptoms [&nbsp;Time&nbsp;Frame:&nbsp;Within the 15-day solicited follow-up period after any dose of study vaccine&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:0eab1f5dc6ca616c50b4cf684701b722' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence of unsolicited symptoms according to WHO classification. [&nbsp;Time&nbsp;Frame:&nbsp;Within 42 days after dose 1 and dose 2&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:1da547d1dbe1b5e4fd0d9fc909bcf4ca' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence of serious adverse events [&nbsp;Time&nbsp;Frame:&nbsp;Throughout the entire study period&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cce437a4ddd345d5bbc1d6e87b853627' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Serum rotavirus immunoglobulin A (IgA) antibody titers [&nbsp;Time&nbsp;Frame:&nbsp;At visits 1, 3 and 4 and at all Visits for pilot efficacy subset&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:42bf2495bbe4ddaf21835e6ec5d96660' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Rotavirus seropositivity status [&nbsp;Time&nbsp;Frame:&nbsp;Before dose 1 and at the end of the study&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:ec982d5521cd55889ffe0a84c1ebda7c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Vaccine take (for pilot efficacy subset only) [&nbsp;Time&nbsp;Frame:&nbsp;2 months after dose 1&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:ace82616c5d43a84264af47928ae0214' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:29b74958d9b0145d8db430778d2d8171' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Antibody concentrations to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [&nbsp;Time&nbsp;Frame:&nbsp;Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:29b74958d9b0145d8db430778d2d8171' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b790bbf215b21af15d9d956ff7eaed9c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Anti-PRP, anti-diphtheria, anti-tetanus, anti-polio type 1, 2 and 3 seroprotection status. [&nbsp;Time&nbsp;Frame:&nbsp;Two months after dose 2 and at the end of the study.&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:b790bbf215b21af15d9d956ff7eaed9c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Anti-PT, anti-FHA, anti-PRN, pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (only in US subjects) seropositivity status. [&nbsp;Time&nbsp;Frame:&nbsp;Two months after dose 2 and at the end of the study.&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:be0243e5324af53aee22bce4feb321dc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:bee3d6aacb256ee748d958911d1d15a9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Seropositivity status and Geometric mean titres (GMTs) of rotavirus IgA for breast fed infants compared with formula fed infants [&nbsp;Time&nbsp;Frame:&nbsp;Two months after dose 2.&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:bee3d6aacb256ee748d958911d1d15a9' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence of rotavirus gastroenteritis (in a pilot efficacy subset of subjects) [&nbsp;Time&nbsp;Frame:&nbsp;Two weeks after dose 2 until the end of the rotavirus season following vaccination.&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:1f05f6970dc62eccbddfec0e67b7ba84' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f7ed5d7288bdc674db6b4425c8f22311' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of hight fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:f7ed5d7288bdc674db6b4425c8f22311' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>An Open Label, Randomised, Single Dose, Three-Way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male a</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:df7e90b2b9ff925665759c765afbf70f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8c02eb1185ba0999955195f96b806afd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion:\n<ul>\n<li>Healthy as determined by responsible physician.</li>\n<li>Male or female between 18 to 65 years old.</li>\n<li>Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.</li>\n<li>Males that agree to use appropriate method of contraception for appropriate amount of time.</li>\n<li>Neither too fat nor too thin.</li>\n<li>Capable of giving written informed consent and being compliant with requirements within the informed consent.</li>\n</ul>\n</p><p> Exclusion:\n<ul>\n<li>Any current medical or psychiatric illness.</li>\n<li>Any history of chronic medical or psychiatric illnesses.</li>\n<li>Previous or current alcohol or drug abuse/dependence including nicotine.</li>\n<li>Female subjects must not be breastfeeding or been breastfeeding for a month.</li>\n<li>Serum prolactin exceeding normal range.</li>\n<li>Personal or family history of prolonged QTc syndrome.</li>\n</ul>\n</p>', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:8c02eb1185ba0999955195f96b806afd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7d415565b0dca08068410bdfc2e6d7d3' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will consist of 4 parallel cohorts of healthy volunteers(elderly male, elderly female, young male and young female. Subjects will receive either GSK372475 1.5mg or placebo for 28 days</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:7d415565b0dca08068410bdfc2e6d7d3' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9650bba0bb2d21d9c065e30aee4570bc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:9650bba0bb2d21d9c065e30aee4570bc' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Placebo-Controlled, Single-Blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Volunteers.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:52d7129350071181cab086cb0f7ba5fa' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:07cf6ec28a50b6f07eb45f9b3fab6847' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion:\n<ul>\n<li>A healthy man or woman</li>\n<li>18 - 50 years old</li>\n<li>Neither too fat, nor too thin</li>\n<li>Female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit.</li>\n<li>Female subjects must not be breast feeding and should not have been breast feeding for a month.</li>\n<li>Male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up.</li>\n<li>Subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study.</li>\n</ul>\n</p><p> Exclusion:\n<ul>\n<li>Any current medical or psychiatric illness</li>\n<li>Any history of chronic medical or psychiatric illnesses</li>\n<li>Previous or current alcohol or drug abuse/dependence including nicotine</li>\n<li>Personal or family history of prolonged QTc syndrome</li>\n</ul>\n</p>', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:07cf6ec28a50b6f07eb45f9b3fab6847' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:2a68dfc14794175973dfc40349eda6e6' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:472d0943d35917b77ae623e2c011e50a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b8cf37265b1ce199dc3c678a3095d80d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:b8cf37265b1ce199dc3c678a3095d80d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3a207af9963b774f621523f5911c7189' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>INC1 Screening plasma HIV-1 RNA viral load &gt;5000 copies/mL</li>\n<li>INC2 Self-identification as having any non-White/Caucasian European geographic ancestry (i.e., an individual is eligible if she/he does not have any White/Caucasian European ancestry; OR an individual is eligible if she/he indicates a mix of White/Caucasian European ancestry AND one or more other geographic ancestries);</li>\n<li>INC3 Adult (&#8805;18 years)</li>\n<li>INC4 Antiretroviral-na&#239;ve (no treatment with any antiretroviral drug in the 28 days prior to study entry and &#8804;14 days of treatment ever with any antiretroviral drug)</li>\n<li>INC5 Negative test for the HLA-B*5701 allele</li>\n<li>INC6 Ability and willingness to give written informed consent</li>\n<li>INC7 Either gender is eligible, but enrollment of at least two female subjects to every one male subject is strongly encouraged. A female subject is eligible to participate in the study if she is of: a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal); or, b. Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the Prescribing Information and the instructions of a physician): i. Agreement for complete abstinence from intercourse from 2 weeks prior to administration of investigational products, throughout the study, and for 2 weeks after discontinuation of all study medications; ii. Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); iii. Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion); iv. Any other method with published data showing that the lowest expected failure rate for the method is less than 1% per year. Note: Hormonal contraception is not recommended for use in conjunction with Lexiva due to decreased efficacy of contraception as well as increased risk of hepatic transaminase elevation. All applicable Prescribing Information should be consulted. v. Sterilization (female subject or male partner of female subject) </li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>EXC1 Screening HIV-1 genotype indicating the presence of any of the following mutations in the reverse transcriptase (RT) region: K65R, L74V, K103N, Y115F, Y181C/I, Y188C/L/H or G190S/A, or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, associated with resistance to abacavir, lamivudine, or efavirenz; OR within the protease region, detection of any of the following mutations associated with resistance to fosamprenavir or ritonavir: I50V, I54L/M, I84V, or the combination of the two mutations V32I+I147V</li>\n<li>EXC2 Positive for Hepatitis B surface antigen (HBsAg+)</li>\n<li>EXC3 Requirement for active treatment for hepatitis C virus infection, as indicated by both a positive HCV serology AND either:\n<ol>\n<li>Decompensated liver disease, or</li>\n<li>Aspartate aminotransferase (AST) &gt;3X the upper limit of normal (ULN), or</li>\n<li>Alanine aminotransferase (ALT) &gt;3X the ULN</li>\n</ol>\n</li>\n<li>EXC4 Currently pregnant, intending to become pregnant during the study period, or breast-feeding</li>\n<li>EXC5 Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), any vaccinations, systemic cytotoxic chemotherapy, or investigational therapy within 28 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. Acute treatment (less than 21 days) with larger doses of corticosteroids for acute therapy is permitted.</li>\n<li>EXC6 Active or suspected drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements</li>\n<li>EXC7 Judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results</li>\n<li>EXC8 Active or acute CDC Clinical Category C event at screening. (Note: Treatment for the acute event must have been completed at least 28 days prior to screening.)</li>\n<li>EXC9 Clinically relevant pancreatitis or clinically relevant hepatitis at screening</li>\n<li>EXC10 Hgb&lt;8g/dl, platelet count &lt;50,000/mm3, calculated creatinine clearance &lt;50ml/min via Cockroft-Gault equation, or AST or ALT &gt; 5X the ULN</li>\n<li>EXC11 Any Grade 4 laboratory abnormality</li>\n</ul>\n</p>', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:3a207af9963b774f621523f5911c7189' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives &amp; outcome measures of the primary phase/study.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:aec247f4e2d286fa2030482cf1ea9c69' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Seroconversion Rates (SCR) [&nbsp;Time&nbsp;Frame:&nbsp;Day 21&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:f0cd548cc14ca3fedc4875c501eb0f46' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Seroconversion Factors (SCF) [&nbsp;Time&nbsp;Frame:&nbsp;Day 21&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:c345ab62354e7829d97306305deb5b84' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains [&nbsp;Time&nbsp;Frame:&nbsp;Days 0 and 21&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:34613e4e456610b10a1db2e7218f7b83' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:59697c50d90496c01d9ee7404bd2de5d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Seroprotection Rates (SPR) [&nbsp;Time&nbsp;Frame:&nbsp;Days 0 and 21&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:59697c50d90496c01d9ee7404bd2de5d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Occurrence, intensity and investigator\'s assessment of relationship to vaccine of SAEs and medically attended events [&nbsp;Time&nbsp;Frame:&nbsp;During the entire study period&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:515e73c5575ce83e72bcf43ef5245a72' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and tenofovir</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:f5cb79b37eb53155e0860cee6e3312e7' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Plasma tenofovir steady-state AUC(0-24), Cmax and Ct following administration of TDF 300 mg q24h for 7 days alone and following co-administration with GSK1349572 50 mg q24h for 5 days.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:ccb35fa97644614581856295c00d31b7' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:282baf83034d0f63e4bc52c14a7c4f82' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:8019d248e95ed7393a167c4bedd45ce3' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:fc206dd765618d504431afedaa9e0bdd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3f7cbed5aa0417070d0dfba4e3226888' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of &lt;/= 2.</li>\n<li>Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Radiation to &gt;/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,</li>\n<li>Any uncontrolled intercurrent illness,</li>\n<li>Pregnant or breastfeeding,</li>\n<li>HIV positive</li>\n</ul>\n</p>', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:3f7cbed5aa0417070d0dfba4e3226888' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:69e5d36da14b0125ca210a14e293f412' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been associated with poor prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:69e5d36da14b0125ca210a14e293f412' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Phase 2 Study of the MET RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cf737db8eb44958421b6d89a5150913c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ol>\n<li>The subject has a histologically or cytologically confirmed diagnosis of SCCHN and\n<ul>\n<li>has recurrent and/or metastatic disease</li>\n<li>is not eligible for curative intent surgery or radiotherapy</li>\n<li>has no history of uncontrolled tumor bleeding including hemoptysis in patients with documented pulmonary metastasis.</li>\n</ul>\n</li>\n<li>The subject has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =20 mm with conventional techniques, or as =10 mm with spiral computerized tomography (CT) scan.</li>\n<li>Subject is capable of swallowing capsules.</li>\n<li>Fifteen unstained slides of tumor tissue, archival or fresh, or paraffin block are available, and there is confirmation that samples have been sent for analysis at the central laboratory.</li>\n<li>The subject is at least 18 years old.</li>\n<li>The subject has an Eastern Cooperative Oncology Group (ECOG) performance status =1.</li>\n<li>In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level =20 &#181;g/dL (552 nmol/L) 30-90 minutes after injection of ACTH.</li>\n<li>The subject has organ and marrow function as follows: absolute neutrophil count (ANC) =1500/mm3, platelets =100,000/mm3, hemoglobin =9 g/dL, bilirubin =1.5 mg/dL, serum creatinine =1.5 mg/dL and/or calculated creatinine clearance =60 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the upper limit of normal if no liver involvement or =5 times the upper limit of normal with liver involvement.</li>\n<li>The subject has signed the informed consent document.</li>\n<li>Sexually active subjects must use a medically accepted method of contraception during the course of the study.</li>\n<li>Female patients of childbearing potential must have a negative pregnancy test at enrollment.</li>\n<li>The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed =5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).</li>\n</ol>\n</p><p> Exclusion Criteria:\n<ol>\n<li>The subject has received radiation to &gt;25% of his or her bone marrow within 30 days of GSK1363089 treatment.</li>\n<li>The subject has received an investigational drug within 30 days (or &lt;5.5 half lives) of the first dose of study drug.</li>\n<li>The subject has received more than one regimen of systemic anticancer therapy for disease that has recurred or is metastatic. This may include either single-agent or combination cytotoxic chemotherapy with radiotherapy or anti-EGFR treatment (eg, cetuximab). Adjuvant or neoadjuvant systemic chemotherapy does not count as a regimen for recurrent or metastatic disease.</li>\n<li>The subject has progressed within 6 months after completion of curative intent (definitive) treatment for localized/locoregionally advanced disease.</li>\n<li>The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade =1 from adverse events (AEs) due to investigational drugs or other medications that were administered more than 30 days before study enrollment with the sole exception of persistent Grade 2 peripheral neuropathy in patients who have previously received platinum-based therapy.</li>\n<li>The subject has known brain metastases.</li>\n<li>The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active alcoholism, or psychiatric illness that would limit compliance with study requirements.</li>\n<li>The subject is pregnant or breastfeeding.</li>\n<li>The subject is known to be positive for the human immunodeficiency virus (HIV).</li>\n<li>The subject has an allergy or hypersensitivity to components of the GSK1363089 formulation.</li>\n</ol>\n</p>', created = 1283571882, expire = 1283658282, headers = '', serialized = 0 WHERE cid = '1:713219480bde34eb2143bbabc534249b' in /persistent/html/includes/cache.inc on line 109.

Evaluating a Heart Magnetic Resonance Imaging (MRI) Procedure and the Effect of Fish Oil Supplementation in People Who Have Recently Had a Heart Attack (The PROSPECT-CMR Study)

Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.

Background information
Other unique IDs: 
591
1 R01 HL091157-01A1

Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.

This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.

Background information
Other unique IDs: 
444563/005

A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.

Trial phase: 
Phase I
Recruitment status: 
Completed

Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of hight fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.

Background information
Trial ID: 
NCT00728897
Other unique IDs: 
DAN111283
Official title: 

An Open Label, Randomised, Single Dose, Three-Way Crossover Study to Investigate the Relative Bioavailability of a 100mg Capsule Compared to Four 25mg GSK598809 Capsules and the Effect of Food on the Pharmacokinetics of the 100mg Capsule in Healthy Male a

Detailed description: 

 

Number to be enrolled: 
16 patients

GSK372475 PK Study in Healthy Volunteers

This study will consist of 4 parallel cohorts of healthy volunteers(elderly male, elderly female, young male and young female. Subjects will receive either GSK372475 1.5mg or placebo for 28 days

Background information
Other unique IDs: 
105467

A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers.

Trial phase: 
Phase I
Recruitment status: 
Completed

Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence. It is important to evaluate how this drug interacts in healthy smokers. The study is planned to consist of a single part, with 4 dosing periods. Subjects will receive 3 escalating doses of GSK598809 and 1 dose of placebo. There will be at least 1 week of wash out between doses. In each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. The actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. It is expected that the duration of this study will be approximately 10 weeks.

Background information
Trial ID: 
NCT00728052
Other unique IDs: 
DAN111282
Official title: 

A Placebo-Controlled, Single-Blind, Randomised, Human Volunteer Study Investigating the Tolerability and Pharmacokinetics of Escalating Single Oral Doses (75mg and Above) of GSK598809 in Otherwise Healthy Volunteers.

Detailed description: 

 

Number to be enrolled: 
1 patients

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.

Background information
Trial ID: 
NCT00727597
Other unique IDs: 
COL 110408
Official title: 

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Detailed description: 

The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.

Number to be enrolled: 
100 patients
Acronym: 
SUPPoRT

Immunogenicity and Safety of GSK Biologicals' FluLaval® TF

The present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.

Background information
Other unique IDs: 
112219

GSK1349572 Drug Interaction With Tenofovir

A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and tenofovir

Background information
Other unique IDs: 
111604

A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Background information
Trial ID: 
NCT00726323
Other unique IDs: 
MET111644
Official title: 

A Phase 2 Study of the c-Met RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Papillary Renal-Cell Carcinoma

Detailed description: 

 

Number to be enrolled: 
71 patients

Phase 2 Study of GSK1363089 (Formerly XL880) in Adults With Squamous Cell Cancer of the Head and Neck

Trial phase: 
Phase II
Recruitment status: 
Recruiting

This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor [KDR]). Since MET overexpression has been associated with poor prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.

Background information
Trial ID: 
NCT00725764
Other unique IDs: 
MET111646
Official title: 

A Phase 2 Study of the MET RTK Inhibitor GSK1363089 (Formerly XL880) in Subjects With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Detailed description: 

 

Number to be enrolled: 
41 patients
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