A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer (Solid Tumors)

Treatments: Drug: BMS-690514

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420186

CA187-004

Details and patient eligibility

About

The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
• Centrally located squamous cell carcinoma of the lung is permitted
• ECOG performance status of 0-1
• Life expectancy of at least 3 months
• Men and women age 18 and above

Exclusion criteria

• Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
• Peripheral neuropathy ≥Grade 1 for any reason
• History of thromboembolic disease or bleeding diatheses within the last 6 months
• Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
• Serious, uncontrolled medical disorder or active infection
• Uncontrolled or significant cardiac disease
• Uncontrolled hypertension (150/100)
• Allergy to Cremophor EL®

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

1

Experimental group

Treatment:

Drug: BMS-690514