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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasms | Drug: BMS-754807 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
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 |
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 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Japan | |
Local Institution | |
Chuo-Ku, Tokyo, Japan, 104-0045 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00898716 |
Other Study ID Numbers: |
CA191-003 |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | November 30, 2011 |
Last Verified: | July 2010 |