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

S*BIO

Status and phase: Completed; Phase 1

Conditions: Myelodysplastic Syndrome; Solid Tumors; Hematologic Malignancies

Treatments: Drug: Azacitidine; Drug: SB939

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741234

SB939-2006-001

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

A

Experimental group

Description:

Advanced solid tumors

Treatment:

Drug: SB939

B

Experimental group

Description:

Advanced hematologic malignancies

Treatment:

Drug: SB939

C

Experimental group

Description:

Myelodysplastic Syndrome

Treatment:

Drug: Azacitidine

Drug: SB939