PII Study of BMS-582664 in Subjects with Advanced Cancer
Research type
Research Study
Full title
A Randomised Discontinuation Study of Brivanib alaninate (BMS-582664) versus Placebo in Subjects with Advanced Tumors
Contact name
Stan Kaye
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2008-000087-16
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Brivanib is an inhibitor of certain receptors, known to have a role in the growth of new blood vessels within tumors, and ultimately tumor growth and further spreading. Recent experiences with similar compounds have shown that the tumor size stabilises rather than reduces. The initial group of patients will include those with advanced or pre-treated non-small cell lung cancer, transitional cell carcinoma, soft tissue carcinoma, gastric/oesophageal adenocarcinoma or pancreatic carcinoma. The main purpose of the study is to determine the effects of brivanib compared to a dummy therapy (placebo) in patients with stable disease after an initial period of brivanib therapy. All patients enrolled into the study will initially receive brivanib. After the initial treatment period those patients with stable disease will receive either brivanib daily or placebo. Neither the patient nor the site will know which they are receiving. The tumor type and the quantity of receptors present will also be taken into account. Patients showing more than a 50% reduction in tumor size will continue to receive brivanib treatment. Those showing more than a 25% increase in tumor size will stop treatment and discontinue from the study. During the second part of the study patients whose tumor size increases and receiving placebo will be offered to restart brivanib. During the study patients will undergo physical examinations, weight and vital signs, and have blood samples taken at all study visits. Patients will have urine taken at some visits, and will undergo one electrocardiogram (ECG) and an echocardiogram (ECHO) every 12 weeks (both procedures assess heart function). The patients?? tumor size will be assessed every 6 weeks by CT scan. In order to assess the quantity of receptors present a tumor sample will be required either from the original biopsy if available or a new fresh biopsy sample.
REC name
London - South East Research Ethics Committee
REC reference
08/H1102/113
Date of REC Opinion
16 Mar 2009
REC opinion
Further Information Favourable Opinion