Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00898716
First received: May 11, 2009
Last updated: November 29, 2011
Last verified: July 2010
  Purpose

The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.


Condition Intervention Phase
Neoplasms
Drug: BMS-754807
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-754807 in Patients With Solid Tumors in Japan

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days [ Time Frame: Within the first 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the safety and tolerability [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: Yes ]
  • To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: Yes ]
  • To assess the metabolic effect on blood glucose [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: No ]
  • To assess any preliminary evidence of anti-tumor activity [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: Yes ]
  • To explore potential biomarkers of biological response [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-754807 Drug: BMS-754807
Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response

  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 0-1

Exclusion Criteria:

  • Any disorder with dysregulation of glucose homeostasis
  • Dumping syndrome
  • History of glucose intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898716

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: NCT00898716     History of Changes
Other Study ID Numbers: CA191-003
Study First Received: May 11, 2009
Last Updated: November 29, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014