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
18 Years
N/A
Open (Enrolling)
Both
Cancer (Solid Tumors)
Both
Cancer (Solid Tumors)
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 Institute | Buffalo, New York 14263 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
