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

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Metastatic Solid Tumors
• Interventions: Drug: BMS-754807; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00793897
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2009-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential allocation of patients in two dosing schedules	Carboplatin	-
Sequential allocation of patients in two dosing schedules	Paclitaxel	-
Sequential allocation of patients in two dosing schedules	BMS-754807	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of