A Study of BMS-663513 Administered in Combination With Chemotherapy to Subjects With Advanced Solid Malignancies

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: BMS-663513

Study type: Interventional

Funder types: Industry

Identifiers

NCT00351325

CA186-004

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of multiple escalating doses of BMS-663513 when given in combination with paclitaxel and carboplatin.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good activity level
• Life expectancy of ≥ 6 months
• Solid tumor malignancy for which paclitaxel and carboplatin are appropriate

Exclusion criteria

• Major surgery within 4 weeks
• Any concurrent cancer
• History of autoimmune diseases
• Symptomatic bowel obstruction
• Continued use of steroids
• Symptomatic brain metastases
• Current nerve damage in fingers/toes
• Positive for HIV, hepatitis B/C
• White blood cells < 3,000
• Hemoglobin < 9
• Platelets < 100,000
• ALT/AST and/or alkaline phosphatase >= 2.5 x ULN
• Creatine > 1.5
• Prior BMS-663513

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 1 patient group

dose escalation

Experimental group

Treatment:

Drug: BMS-663513