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

Completed · Phase 1

Conditions studied: Cancer (Solid Tumors)

In brief

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

Key facts

Study ID

NCT00420186

Run by

Bristol-Myers Squibb

People needed

37

Starts

2007-10-01

Expected to finish

2012-02-01

Last updated by the study team

2016-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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®

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Local Institution — Ottawa, Ontario, Canada
• Local Institution — Manchester, Greater Manchester, United Kingdom

Full record on ClinicalTrials.gov

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