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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01018745
First received: November 24, 2009
Last updated: January 6, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BMS-907351 (XL184)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter ] [ Designated as safety issue: Yes ]
  • To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors [ Time Frame: Day 1, 5, 15, 19 and 29 ] [ Designated as safety issue: No ]
  • To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity [ Time Frame: Day 1, 5, 15, 19, 29 and every 4 weeks thereafter ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-907351 (XL184) Drug: BMS-907351 (XL184)
Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Subject has uncontrolled intercurrent illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018745

Locations
Japan
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01018745     History of Changes
Other Study ID Numbers: CA205-001
Study First Received: November 24, 2009
Last Updated: January 6, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014