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

September 28, 2016 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution
  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Local Institution
  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • panHER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
upon occurrence

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe anti-tumor activity
Time Frame: upon occurence
upon occurence
Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research
Time Frame: upon occurence
upon occurence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CA187-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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