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

A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors

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

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