Trial record 18 of 57 for:    cabozantinib

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
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 April 17, 2014