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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00420186
First received: January 8, 2007
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Cancer (Solid Tumors)
Drug: BMS-690514
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Describe anti-tumor activity [ Time Frame: upon occurence ] [ Designated as safety issue: No ]
  • Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research [ Time Frame: upon occurence ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BMS-690514
Tablets / IV, Oral / IV, 100 to 300 mg / Paclitaxel (200 mg/m2) / Carboplatin dose (mg) = Target AUC (6) x (GFR + 25), Once daily Days 4-19, up to 24 mos
Other Name: panHER

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420186

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
United Kingdom
Local Institution
Manchester, Greater Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00420186     History of Changes
Other Study ID Numbers: CA187-004
Study First Received: January 8, 2007
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014