A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
A Phase I Multiple Ascending Dose Study of BMS-844203 (CT-322) Monotherapy in Japanese Patients With Solid Tumors
Inclusion Criteria:
- Advanced or metastatic solid tumors for whom the standard of care is ineffective or
inappropriate
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group performance 0-1
Exclusion Criteria:
- Subject has uncontrolled diabetes or hypertension
- Clinical significant bleeding diathesis or coagulopathy
- Thrombotic or embolic cerebrovascular accident
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine recommended dose for Phase 2 study of CT-322
Outcome Time Frame:
Within the first 28 days
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:
CA196-007
NCT ID:
NCT01146171
Start Date:
November 2013
Completion Date:
January 2015
Related Keywords:
- Neoplasms
- Neoplasms
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