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

Completed · Phase 1

Conditions studied: Cancer, Tumor

In brief

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.

Key facts

Study ID

NCT00329004

Run by

Bristol-Myers Squibb

People needed

89

Starts

2006-08-01

Expected to finish

2009-07-01

Last updated by the study team

2011-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Indiana University Med Center — Indianapolis, Indiana, United States
• The University Of Texas Md Anderson Cancer Center — Houston, Texas, United States
• Local Institution — Ottawa, Ontario, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Toulouse, France
• Local Institution — Villejuif, France
• Local Institution — Barcelona, Spain

Full record on ClinicalTrials.gov

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