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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00329004
First received: May 19, 2006
Last updated: January 24, 2011
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
Tumor
 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 Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety [ Time Frame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks ] [ Designated as safety issue: Yes ]
  • Highest dose tolerated [ Time Frame: continuous medical review of adverse event reports ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effective dose or doses of BMS-690514 [ Time Frame: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BMS-690514
Tablets, Oral, up to 300 mg, once daily, 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:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329004

Locations
United States, Indiana
Indiana University Med Center
Indianapolis, Indiana, United States, 46202
United States, Texas
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution
Toronto, Ontario, Canada, M5G 2M9
France
Local Institution
Toulouse, France, 31052
Local Institution
Villejuif, France, 94805
Spain
Local Institution
Barcelona, Spain, 08035
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00329004     History of Changes
Other Study ID Numbers: CA187-002
Study First Received: May 19, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Solid Tumors

ClinicalTrials.gov processed this record on May 23, 2013