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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00329004
Collaborator
(none)
89
Enrollment
7
Locations
1
Arm
35
Duration (Months)
12.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 1, 2006
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: BMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
Other Names:
  • panHER

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety [results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks]

    2. Highest dose tolerated [continuous medical review of adverse event reports]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Indiana University Med Center Indianapolis Indiana United States 46202
    2 The University Of Texas Md Anderson Cancer Center Houston Texas United States 77030
    3 Local Institution Ottawa Ontario Canada K1H 8L6
    4 Local Institution Toronto Ontario Canada M5G 2M9
    5 Local Institution Toulouse France 31052
    6 Local Institution Villejuif France 94805
    7 Local Institution Barcelona Spain 08035

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00329004
    Other Study ID Numbers:
    • CA187-002
    First Posted:
    May 24, 2006
    Last Update Posted:
    Jan 25, 2011
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Solid Tumors
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jan 25, 2011