We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898716
First Posted: May 12, 2009
Last Update Posted: November 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Multiple Ascending Dose Study of BMS-754807 in Patients With Solid Tumors in Japan

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 ]

Secondary Outcome Measures:
  • To assess the safety and tolerability [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  • 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 ]
  • To assess the metabolic effect on blood glucose [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  • 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 ]
  • To assess any preliminary evidence of anti-tumor activity [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  • To explore potential biomarkers of biological response [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00898716     History of Changes
Other Study ID Numbers: CA191-003
First Submitted: May 11, 2009
First Posted: May 12, 2009
Last Update Posted: November 30, 2011
Last Verified: July 2010