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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329004
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : January 25, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Tumor Drug: BMS-690514 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1 Drug: BMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
Other Name: panHER

Primary Outcome Measures :
  1. Safety [ Time Frame: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks ]
  2. Highest dose tolerated [ Time Frame: continuous medical review of adverse event reports ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT00329004

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
Local Institution
Toulouse, France, 31052
Local Institution
Villejuif, France, 94805
Local Institution
Barcelona, Spain, 08035
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb