Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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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

Official Title
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A Phase I/II Trial of BMS-754807 in Combination With Cetuximab (Erbitux®) in Subjects With Advanced or Metastatic Solid Tumors

Conditions
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Colorectal Cancer, Head and Neck Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Drug: BMS-754807
* Drug: cetuximab (Erbitux®)


Participation Criteria
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Eligibility Criteria
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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 must be able to provide 2 fresh tumor biopsy samples must have failed one prior cetuximab-containing treatment Exclusion Criteria: Symptomatic brain metastasis Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed Any condition requiring chronic use of steroids Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms) History of glucose intolerance History of cetuximab infusion reactions Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-754807 + cetuximab<br>Combination | Drug: BMS-754807<br>* Tablets, Oral, doses vary during dose escalation, once daily, varies - treatment is continued to disease progression or MD/subject/sponsor decision<br>Drug: cetuximab (Erbitux®)<br>* 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<br>* Other names: Eributux®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |