A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Completed · Phase 1
Conditions studied: Solid Tumors, Hematologic Malignancies, Myelodysplastic Syndrome
In brief
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.
Key facts
- Study ID
- NCT00741234
- Run by
- S*BIO
- People needed
- 85
- Starts
- 2007-04-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Wisconsin-Madison — Madison, Wisconsin, United States
- National University Hospital — Singapore, Singapore
- National Cancer Center — Singapore, Singapore
- Singapore General Hospital — Singapore, Singapore
Full record on ClinicalTrials.gov
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