Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BMS-817378

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792558

CA195-001

Details and patient eligibility

About

The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: BMS-817378