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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

May 19, 2006
January 24, 2011
August 2006
July 2009   (final data collection date for primary outcome measure)
  • 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 ]
Safety: results of weekly vital sign measurements, ECGs, laboratory tests and physical exams; Safety: echocardiograms every 8 weeks, Highest dose tolerated: continuous medical review of adverse event reports.
Complete list of historical versions of study NCT00329004 on ClinicalTrials.gov Archive Site
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 ]
Effective dose of doses of BMS-690514: tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports
Not Provided
Not Provided
 
A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid Tumors
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Tumor
Drug: BMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
Other Name: panHER
Experimental: 1
Intervention: Drug: BMS-690514
Soria JC, Baselga J, Hanna N, Laurie SA, Bahleda R, Felip E, Calvo E, Armand JP, Shepherd FA, Harbison CT, Berman D, Park JS, Zhang S, Vakkalagadda B, Kurland JF, Pathak AK, Herbst RS. Phase I-IIa study of BMS-690514, an EGFR, HER-2 and -4 and VEGFR-1 to -3 oral tyrosine kinase inhibitor, in patients with advanced or metastatic solid tumours. Eur J Cancer. 2013 May;49(8):1815-24. doi: 10.1016/j.ejca.2013.02.012. Epub 2013 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
July 2009
July 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Spain
 
NCT00329004
CA187-002
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP