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

Phase 1

Withdrawn

• Conditions: Advanced Solid Tumors
• Interventions: Drug: BMS-817378

• Registration Number: NCT00792558
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Status Verified: 2009-01
• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	BMS-817378	-

Primary Outcome Measures

Name	Time	Method
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers	Within the first 21 days after first dose of BMS-817378

Secondary Outcome Measures

Name	Time	Method
Describe preliminary evidence for anti-tumor activity of BMS-817378	Every 6 weeks
Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors	All time points while subject is on study
Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)	Day 22 +/-2
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833	Days 1 and 15
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction	All time points while subject is on study

Trial Locations

Locations (1)

Local Institution; 🇸🇬 Singapore, Singapore