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

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ClinicalTrials.gov Identifier: NCT00898716
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 30, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: BMS-754807 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. To assess the safety and tolerability [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  2. 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 ]
  3. To assess the metabolic effect on blood glucose [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  4. 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 ]
  5. To assess any preliminary evidence of anti-tumor activity [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]
  6. To explore potential biomarkers of biological response [ Time Frame: Day 1, 8, 15, 22, 29, thereafter every 2 weeks ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00898716     History of Changes
Other Study ID Numbers: CA191-003
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: July 2010