Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
Phase 1 Multiple Ascending Dose Study of BMS-833923 (XL139) in Subjects With Solid Tumors
Inclusion Criteria:
- Subjects with advanced or metastatic solid tumors refractory to, or relapsed from,
standard therapies or for which there is no known effective treatment
- Men and woman, 20 years of age and above
Exclusion Criteria:
- Subjects with symptomatic brain metastasis or active brain metastasis requiring
treatments
- Inability to swallow oral medication
- Uncontrolled or significant cardiovascular disease
- Inadequate bone marrow function
- Inadequate hepatic function
- Inadequate renal function
- Pancreatitis
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of Dose Limiting Toxicity (DLT) and observed adverse events
Outcome Time Frame:
Within the first 28 days of treatment
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA194-010
NCT ID:
NCT01413906
Start Date:
November 2011
Completion Date:
November 2012
Related Keywords:
- Cancer
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