NCT00741234

A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: S*BIO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Solid Tumors
• Hematologic Malignancies
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	SB939	SB939 taken orally in a 4-week cycle.
DRUG	Azacitidine	Azacitidine taken orally with SB939 in a 4-week cycle

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-08-26
• Last updated: 2012-04-23

Locations

5 sites across 2 countries: United States, Singapore