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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors; Metastatic Solid Tumors

Treatments: Drug: BMS-754807; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793897

CA191-005

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Sequential allocation of patients in two dosing schedules

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: BMS-754807