A Randomized Discontinuation Study of Brivanib alaninate (BMS-582664) versus Placebo in Subjects with Advanced Tumors.

Phase 2

Completed

Conditions: Advanced Tumors
10027655

Registration Number: NL-OMON32125

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• Histologic or cytologic confirmed diagnosis of a solid tumor (non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma and pancreatic cancer including ampulla of Vater tumors) which has progressed on standard therapy or for whom no standard therapy is known.
• Measurable disease
• Men and women, age 18 or older
• Life expectancy at least 3 months
• ECOG performance status 0 or 1 (generally fit and mobile)
• Adequate tumor sample for FGF-2 assay
• Adequate bone marrow, renal and hepatic function
• Adequate recovery from recent surgery and radiation therapy - one week for minor surgery and 8 weeks for major surgery or radiation therapy.
• At least 3 weeks must have relapsed since last dose of chemotherapy or targeted agents providing the subject has recovered from all toxicities. At least 8 weeks must have elapsed from the last dose of bevacizumab, prior to beginning protocol therapy.

Exclusion Criteria

• Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during study and up to 12 weeks after the last dose of drug, are pregnant or breastfeeding or have a positive pregnancy test on enrollment or prior to investigational product administration.
• Sexually active fertile men not using effective birth control if their partners are WOCBP, including up to 12 weeks after the last dose of investigational product.
• Actual diagnosis of brain metastasis or any known signs and symptoms, unless confirmed negative by means of a CT scan.
• Centrally cavitating lung lesions.
• History of thrombo-embolic disease within the last six months requiring therapy.
• Other primary malignancy except carcinoma in situ of cervix or urinary bladder or non-melanoma skin cancer.
• History of poor wound healing or non healing ulcers
• Uncontrolled or significant cardiovascular disease including myocardial infarction within 12 months, uncontrolled angina within 12 months; congestive heart failure (Class III-IV New York Heart Association (NYHA) and valvular heart disease grade 2.
• Uncontrolled hypertension even despite appropriate treatment.
• History of stroke, transient ischemic attack or other ischemic event.
• Mental incapacitation or psychiatric illness which would preclude study participation.
• Inability to swallow tablets or untreated malabsorption syndrome.
• History of allergy to brivanib its drug class or related compounds.
• Exposure to any investigational drug within 4 weeks of enrollment
• Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy.
• Prior exposure to brivanib.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is Progressionfree Survival (PFS) time defined as<br /><br>the length of time during<br /><br>and after treatment in which a patient is living with a disease that does not<br /><br>get worse. In this trial the PFS of<br /><br>patients with advanced solid tumours who have achieved disease stabilization<br /><br>after an initial 12week<br /><br>treatment with brivanib and are randomized to continue treatment will be<br /><br>compared to those who are<br /><br>randomized to receive a placebo. Subjects who did not progress nor die will be<br /><br>censored at the date of the last tumour measurement.</p><br>

Secondary Outcome Measures