Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Solid Tumors

Study Overview
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Brief Summary
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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

Official Title
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A Phase I Multiple Ascending Dose Study of BMS-754807 in Combination With Paclitaxel and Carboplatin in Subjects With Advanced or Metastatic Solid Tumors

Conditions
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Advanced Solid Tumors, Metastatic Solid Tumors

Intervention / Treatment
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* Drug: BMS-754807
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with advanced or metastatic solid tumors for whom carboplatin and paclitaxel is considered an appropriate therapy ECOG performance status 0-1 At least 4 weeks between surgery or last dose prior anti-cancer therapy Exclusion Criteria: Symptomatic brain metastases Any disorder or dysregulation of glucose homeostasis {e.g. diabetes) Uncontrolled or significant cardiovascular disease Inadequate bone marrow, liver or kidney function Evidence of > Grade 1 peripheral neuropathy

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential allocation of patients in two dosing schedules<br> | Drug: BMS-754807<br>* Tablets, Oral, escalating doses starting at 10 mg, continuous or intermittent, until disease progression, unacceptable toxicity or at the subject's request<br>* Other names: IGF-IR;Drug: Paclitaxel<br>* Vials, IV, 200 mg/m2, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request<br>* Other names: BMS-181339;Drug: Carboplatin<br>* Vials, IV, 6 mg/mL.min, Day 1 of a 21-day cycle, until disease progression, unacceptable toxicity or at the subject's request<br>* Other names: BMY-26575;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjects with Advanced or Metastatic Solid Tumors or Neoplasms