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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers

Outcome Time Frame:

Within the first 21 days after first dose of BMS-817378

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2009

Completion Date:

November 2010

Related Keywords:

  • Advanced Solid Tumors