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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018944-15 | EudraCT Number |
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The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab
Phase 1: Single Arm Study
Phase 2: Randomized Controlled, Parallel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-908662 (A1) | Experimental | Phase 1 |
|
| Cetuximab (A1) | Experimental | Phase 1 |
|
| BMS-908662 (B1) | Experimental | Phase 2 |
|
| BMS-908662 + Cetuximab (B2) | Experimental | Phase 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-908662 | Drug | Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3 | Assessments every 1-2 weeks while receiving study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as determined by estimates of objective response rates and response duration | Efficacy measured at least every 8 weeks while receiving study drug | |
| Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity | PD assessed during the first 4 weeks on 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 |
|---|---|---|---|---|---|---|
| Oncology Research Associates D/B/A | Scottsdale | Arizona | 85258 | United States | ||
| Usc Norris Comprehensive Cancer Center |
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| BMS-908662 | Drug | Capsules, Oral, (TBD) mg, Q 12 h, Continuously |
|
| Cetuximab | Drug | Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously |
|
| Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin]. | PK measured during first 4 weeks on study |
| Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax]. | PK measured during first 4 weeks on study |
| Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax]. | PK measured during first 4 weeks on study |
| Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)]. | PK measured during first 4 weeks on study |
| Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI]. | PK measured during first 4 weeks on study |
| Los Angeles |
| California |
| 90033 |
| United States |
| Local Institution | Ottawa | Ontario | K1H 1C3 | Canada |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000593770 | BMS 908662 |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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