Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 8, 2007
May 5, 2014
October 2007
February 2012   (final data collection date for primary outcome measure)
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 ]
To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
Complete list of historical versions of study NCT00420186 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Describe anti-tumor activity
  • Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research
Not Provided
Not Provided
 
A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer (Solid Tumors)
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
Experimental: 1
Intervention: Drug: BMS-690514
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2012
February 2012   (final data collection date for primary outcome measure)

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®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00420186
CA187-004
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP