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

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ClinicalTrials.gov Identifier: NCT00420186
Recruitment Status : Completed
First Posted : January 9, 2007
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cancer (Solid Tumors) Drug: BMS-690514 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Describe anti-tumor activity [ Time Frame: upon occurence ]
  2. Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research [ Time Frame: upon occurence ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00420186     History of Changes
Other Study ID Numbers: CA187-004
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: May 2014

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action