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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2009-013766-78 |
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The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-754807 + cetuximab | Experimental | Combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 | Drug | Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of BMS-754807 administered orally (daily schedule) in combination with cetuximab administered standard doses IV (weekly basis) will be determined by observation of dose limiting toxicities during the first 33 days of administration | During and at the end of the first 33 days after the first dose of BMS-754807 is given |
| Measure | Description | Time Frame |
|---|---|---|
| To assess anti-tumor activity as measured by objective responses | every 8 weeks | |
| To evaluate the safety and tolerability of the BMS-754807/cetuximab combination regimen | Ongoing | |
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For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
ECOG status 0 - 1
Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
Dose expansion: CRC (KRAS-WT) and head & neck cancer subjects only
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States | ||
| Duke University Medical Center |
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| cetuximab (Erbitux®) | Drug | IV infusion, IV, 400 mg/m² loading dose, then 250 mg/m², weekly, varies - treatment is continued to disease progression or MD/subject/sponsor decision |
|
|
| To assess the effects of the BMS-754807/cetuximab combination regimen on glucose homeostasis |
| Ongoing |
| Dose Expansion only: To identify biomarkers that are predictive of a response to BMS-754807/cetuximab combination therapy in advanced or metastatic CRC and SCCHN subjects with cetuximab resistance | tumor biopsies before treatment and on day 33 +/- 3 of treatment |
| Durham |
| North Carolina |
| 27710 |
| United States |
| University Of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Local Institution | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545990 | BMS 754807 |
| 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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