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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00741234

Enrollment

Registered

2008-08-26

Start date

2007-04-30

Completion date

2012-03-31

Last updated

2012-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies, Myelodysplastic Syndrome, Solid Tumors

Keywords

SB939, Myelodysplastic Syndrome, Combination with azacitidine, Solid malignancies, Hematologic malignancies, HDAC inhibitor, Refractory to standard therapy

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.

Interventions

DRUGSB939

SB939 taken orally in a 4-week cycle.

DRUGAzacitidine

Azacitidine taken orally with SB939 in a 4-week cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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).	Throughout the study

Secondary

Measure	Time frame
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 determine the pharmacokinetic profile 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

Countries

Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026