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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741234
• Other study ID #: SB939-2006-001
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2008
• Last updated: April 19, 2012
• Start date: April 2007
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: S*BIO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematologic Malignancies
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Neoplasms
• Preleukemia
• Solid Tumors

Intervention

Drug:
• SB939
SB939 taken orally in a 4-week cycle.
• Azacitidine
Azacitidine taken orally with SB939 in a 4-week cycle

Locations

Country	Name	City	State
Singapore	National Cancer Center	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
S*BIO

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	To determine the dose limiting toxicities of SB939		Throughout the study	Yes
Secondary	To determine the pharmacokinetic profile of SB939		Throughout the study	No
Secondary	To assess histone acetylation in PBMC and other biomarkers		Throughout the study	No
Secondary	To document anti-tumor activity		Throughout the study	No