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

NCT ID: NCT00792558

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-11-30

Brief Summary

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

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: EXPERIMENTAL

BMS-817378

Intervention Type: DRUG

Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

Interventions

BMS-817378

Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Adelaide, South Australia, Australia

Local Institution

Nedlands, Western Australia, Australia

Local Institution

Singapore, , Singapore

Countries

Australia; Singapore

Other Identifiers

CA195-001

Identifier Type: -

Identifier Source: org_study_id