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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 5
- Primary Endpoint
- To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Advanced solid tumors
Intervention: SB939 (Drug)
B
Advanced hematologic malignancies
Intervention: SB939 (Drug)
C
Myelodysplastic Syndrome
Intervention: SB939 (Drug)
C
Myelodysplastic Syndrome
Intervention: Azacitidine (Drug)
Outcomes
Primary Outcomes
To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).
Time Frame: Throughout the study
Secondary Outcomes
- To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks(Throughout the study)
- To determine the dose limiting toxicities of SB939(Throughout the study)
- To assess histone acetylation in PBMC and other biomarkers(Throughout the study)
- To document anti-tumor activity(Throughout the study)
- To determine the pharmacokinetic profile of SB939(Throughout the study)