Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BMS-907351 (XL184)

• Registration Number: NCT01018745
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-01
• Status Verified: 2010-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group performance 0-2

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Exclusion Criteria

• Subject has uncontrolled intercurrent illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-907351 (XL184)	BMS-907351 (XL184)	-

Primary Outcome Measures

Name	Time	Method
To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors	Within the first 28 days

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors	Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter
To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors	Day 1, 5, 15, 19 and 29
To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)	Every 8 weeks
To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity	Day 1, 5, 15, 19, 29 and every 4 weeks thereafter

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-Ku, Tokyo, Japan