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A Phase I dose escalation study to determine the safety, tolerability, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in combination with chemotherapy drugs, paclitaxel and carboplatin, in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with paclitaxel and carboplatin for Phase 2 studies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential allocation of patients in two dosing schedules | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 | Drug | Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 | Continuous assessment throughout the duration of the trial: starting with dosing on Day 1 until after 30 day follow-up following the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Biochemical parameters of drug action in serum | assessed every 6 weeks of the study | |
| Metabolic measures: Effects of the drug on parameters of glucose homeostasis | assessed every 6 weeks of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | East Melbourne | Victoria | 3002 | Australia | ||
| Local Institution |
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|
| Paclitaxel | Drug | Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request |
|
|
| Carboplatin | Drug | Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request |
|
|
| Efficacy Measures: PET scans and tumor assessments by CT/MRI | a total of 3 PET scans at screening and during the first 3 weeks. CT/MRI assessed every 6 weeks |
| Pharmacokinetic Measures: Blood samples will be collected during pre-specified times | Day 2, 8 and 15 of Cycle 1 and on Day 1 or Cycle 2 (for Arm A subjects only) |
| Parville |
| Victoria |
| 3050 |
| Australia |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Hamilton | Ontario | L8V 5C2 | Canada |
| Local Institution | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545990 | BMS 754807 |
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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