Trial | NCT00741234  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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 Started
Apr 30
2007
Primary Completion
Mar 31
2012
Study Completion
Mar 31
2012
Last Update
Apr 23
2012
Estimate

Drug SB939

SB939 taken orally in a 4-week cycle.

Drug Azacitidine

Azacitidine taken orally with SB939 in a 4-week cycle

  • Other names: Vidaza

A Experimental

Advanced solid tumors

B Experimental

Advanced hematologic malignancies

C Experimental

Myelodysplastic Syndrome

Criteria 

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.
No Results Posted