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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

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®