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

May 11, 2009
November 29, 2011
September 2009
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00898716 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan
Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
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
Experimental: BMS-754807
Intervention: Drug: BMS-754807
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00898716
CA191-003
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP