Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOX

Study Overview
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Brief Summary
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The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer

Official Title
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A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With FOLFIRI and FOLFOX in Subjects With Advanced Metastatic Solid Tumors

Conditions
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Cancer

Intervention / Treatment
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* Drug: BMS-690514 / FOLFIRI
* Drug: BMS-690514 / FOLFOX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for FOLFIRI or FOLFOX therapy ECOG performance status score 0-1 At least 4 weeks since the last chemotherapy, immunotherapy or radiotherapy with: At least 4 weeks since anti-cancer hormonal therapy OR targeted therapy (for instance tamoxifen or Tarceva) No maximum age for Study Arm A (FOLFOX) 18-65 years of age for Study Arm B (FOLFIRI) Exclusion Criteria: Treatment with other TKIs within the past 4 weeks Active inflammatory bowel disease Major gastrointestinal surgery which may affect absorption of the drug, any surgery within the last 4 weeks History of thromboembolism Severe unmanageable diarrhea Uncontrolled or significant cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: BMS-690514 / FOLFIRI<br>* Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos<br>|
| Active Comparator: B<br> | Drug: BMS-690514 / FOLFOX<br>* Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment |  | throughout the study | 
| dose-limiting toxicity (DLT) |  | assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified | 
| determination of maximum tolerated dose (MTD) |  | during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe anti-tumor of combination therapy |  | Every 8 weeks throughout the study | 
| Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples |  | throughtout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer (solid tumors)