Status:
WITHDRAWN
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
Eligibility Criteria
Inclusion
- Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
- ECOG status 0-1
Exclusion
- WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
- Symptomatic brain metastasis
- Uncontrolled or significant cardiovascular disease
- History of thromboembolic events or bleeding diathesis in past 6 months
- Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
- Serious non-healing wounds, ulcers or bone fractures in past 3 months
- Hemorrhage or bleeding event \>= CTCAE grade 3 in past 4 weeks
- Proteinuria \>= 2+ on dipstick or \>= 1gm/24 hours
- Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
- Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00792558
Start Date
January 1 2009
End Date
November 1 2010
Last Update
September 1 2015
Active Locations (3)
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1
Local Institution
Adelaide, South Australia, Australia, 5000
2
Local Institution
Nedlands, Western Australia, Australia, 6009
3
Local Institution
Singapore, Singapore, 169610