Cancer, Tumor
Conditions
Keywords
Solid Tumors
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.
Interventions
DRUGBMS-690514
Tablets, Oral, up to 300 mg, once daily, up to 24 mos
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks |
| Highest dose tolerated | continuous medical review of adverse event reports |
Secondary
| Measure | Time frame |
|---|---|
| Effective dose or doses of BMS-690514 | tumor measurement by imaging every eight weeks. Continuous medical review of adverse event reports |
Countries
Canada, France, Spain, United States
Outcome results
None listed