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A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer (Solid Tumors)

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Trial Information

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors


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®

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation

Outcome Time Frame:

upon occurrence

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA187-004

NCT ID:

NCT00420186

Start Date:

October 2007

Completion Date:

August 2012

Related Keywords:

  • Cancer (Solid Tumors)

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033