Status:
COMPLETED
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Lead Sponsor:
S*BIO
Conditions:
Solid Tumors
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tumor...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Arms A \& B:
- Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
- ECOG performance status (PS) 0-2;
- Patients must have adequate non-hematologic organ system function.
- Arm C:
- Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
- Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
- ECOG performance status (PS) 0-2;
- Patients must have adequate non-hematologic organ system function.
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00741234
Start Date
April 1 2007
End Date
March 1 2012
Last Update
April 23 2012
Active Locations (5)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
2
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
3
National University Hospital
Singapore, Singapore, 119074
4
National Cancer Center
Singapore, Singapore, 160610