Cancer (Solid Tumors) Clinical Trial
Official title:
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
| Verified date | May 2014 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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® |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institution | Ottawa | Ontario |
| United Kingdom | Local Institution | Manchester | Greater Manchester |
| United States | Roswell Park Cancer Institute | Buffalo | New York |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation | upon occurrence | Yes | |
| Secondary | Describe anti-tumor activity | upon occurence | No | |
| Secondary | Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research | upon occurence | No |