A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

January 24, 2011 updated by: Bristol-Myers Squibb

A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

The purpose of this research study is to determine the highest dose of the drug (BMS-690514) that can be safely given to patients with advanced cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

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
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution
  • France
      • Toulouse, France, 31052
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Med Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 and older
  • Diagnosis of any solid tumor
  • ECOG performance status score 0-1
  • Prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment
  • Treatment with VEGFR2 or HER1 TKI allowed but not both (for instance Avastin or Tarceva, but not both)

Exclusion Criteria:

  • Treatment with other TKIs within the past 4 weeks
  • Patients with brain metastasis
  • Patients with centrally located squamous cell carcinoma of the lung
  • Major gastrointestinal surgery which may affect absorption of the drug
  • Any surgery within last 4 weeks
  • History of thromboembolism
  • Severe unmanageable diarrhea
  • Subjects in Part B will have Non-Small Cell Lung Cancer (NSCLC)
  • Part B/Cohort I erlotinib-naive subjects
  • Part B/Cohort II subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: BMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
Other Names:
  • panHER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated
Time Frame: continuous medical review of adverse event reports
continuous medical review of adverse event reports

Secondary Outcome Measures

Outcome Measure
Time Frame
Effective dose or doses of BMS-690514
Time Frame: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA187-002

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.

Clinical Trials on Cancer

Clinical Trials on BMS-690514

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe