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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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