Bristol-Myers Squibb

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Drug Interaction Study With a Potential Alzheimer's Disease Compound

Trial phase: 
Phase I
Recruitment status: 
Completed

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan

Background information
Trial ID: 
NCT00726726
Other unique IDs: 
CN156-005
Official title: 

Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Midazolam, Warfarin, Caffeine, Omeprazole and Dextromethorphan in Healthy Male Subjects by Administration of a Modified Cooperstown Cocktail

Detailed description: 

 

Number to be enrolled: 
22 patients

Renal Mechanism of Action/Splay vs. TmG

Trial phase: 
Phase I
Recruitment status: 
Not yet recruiting

The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus

Background information
Trial ID: 
NCT00726505
Other unique IDs: 
MB102-020
Official title: 

Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Detailed description: 

 

Number to be enrolled: 
48 patients
Acronym: 
MOA

Comparative Study of Cetuximab and Radiation Vs Surgery Before or After Radiation in Patients With Colorectal Carcinoma

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor cells and cause less damage to normal tissue . Giving the drug Cetuximab together with Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue and possibly nearby lymph nodes. Surgery is usually used in conjunction with other conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation Therapy after surgery may kill any tumor cells that remain after surgery. Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to IV

Background information
Trial ID: 
NCT00725400
Other unique IDs: 
ASI-CRO0000192008
JLRH-0000292008
IORG-0000392008
BMS-192008
IMCL-II-ASI-IORG-92008
ASI-CRCII0708
Official title: 

Phase II Open Label Comparative Study of Cetuximab and Radiation Therapy Vs Surgery Before or After Radiation Therapy in Patients With Stage II to IV Colorectal Carcinoma

Detailed description: 

OBJECTIVES: Primary:

  • Determine the response rate in patients with Colorectal Cancer treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy.

Secondary:

  • To determine the progression-free survival and overall survival of patients treated with these regimens.
  • Compare the treatment compliance of patients treated with these regimens.
  • Compare the safety of these regimens in these patients.

Number to be enrolled: 
450 patients

A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine if Ixabepilone combined with carboplatin is better than paclitaxel combined with carboplatin in a subgroup of patients with non-small cell lung cancer (NSCLC) whose tumors are positive for the βΙII isoform of tubulin

Background information
Other unique IDs: 
CA163-163

A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Background information
Trial ID: 
NCT00722358
Other unique IDs: 
AI447-004
Official title: 

Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1

Detailed description: 

 

Number to be enrolled: 
30 patients

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Recruitment status: 
Recruiting

To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either:

  • unable to construct an adequate immunosuppression regimen due to non-renal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss)

OR

  • at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy

Background information
Trial ID: 
NCT00719225
Other unique IDs: 
IM103-056
Official title: 

Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Detailed description: 

 

Number to be enrolled: 
25 patients

Suboptimal Responders to Adefovir Switching to Entecavir

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

Background information
Trial ID: 
NCT00718887
Other unique IDs: 
AI463-171
Official title: 

A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir

Detailed description: 

 

Number to be enrolled: 
160 patients

Solid Tumors Using Ixabepilone and Dasatinib

Trial phase: 
Phase I
Recruitment status: 
Recruiting

Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects. Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans. All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV). Participants will be placed in 1 of 2 groups. Placement into group 2 will not begin until all spaces in group 1 are filled. Group 1 will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. Group 2 will receive ixabepilone on day 1 of a 3-week cycle (21 days). Dasatinib will be taken twice daily in group 2.

Background information
Trial ID: 
NCT00717704
Other unique IDs: 
WCI-2007-528
Official title: 

A Phase I Study of Ixabepilone Combined With Dasatinib in Patients With Solid Tumors

Detailed description: 

 

Number to be enrolled: 
60 patients

CASTLE (Clopidogrel And Serum Troponin Level Elevation)

Primary Objective: To test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to PCI produce a greater decrease of periprocedural release of biochemical markers (CK, CK-MB, and troponin-T and/or I) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and

  • 24 hours prior to PCI or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before PCI.

Background information
Other unique IDs: 
L_9317

Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib. The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.

Background information
Trial ID: 
NCT00716456
Other unique IDs: 
08-055
Official title: 

A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Detailed description: 

 

Number to be enrolled: 
44 patients
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