A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
NCT00741234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2012-04-23
Summary
This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.
Conditions
Interventions
- DRUG
-
SB939
SB939 taken orally in a 4-week cycle.
- DRUG
-
Azacitidine taken orally with SB939 in a 4-week cycle
Sponsors & Collaborators
-
S*BIO
lead INDUSTRY
Principal Investigators
-
George Wilding, M.D. · University of Wisconsin, Madison
-
Boon Cher Goh, M.D. · National University Hospital, Singapore
-
Han Chong Toh, M.D. · National Cancer Center
-
Charles Chuah, M.D. · Singapore General Hospital
-
Guillermo Garcia-Manero, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-04-30
- Primary Completion
- 2012-03-31
- Completion
- 2012-03-31
Countries
- United States
- Singapore
Study Locations
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