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

Phase 1
18 Years
Not Enrolling
Cancer, Tumor

Thank you

Trial Information

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

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

July 2009

Related Keywords:

  • Cancer
  • Tumor
  • Solid Tumors



Indiana University Med Center Indianapolis, Indiana  46202
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009