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

April 19, 2012 updated by: S*BIO

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 160610
        • National Cancer Center
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Advanced solid tumors
Drug: SB939
SB939 taken orally in a 4-week cycle.
Experimental: B
Advanced hematologic malignancies
Drug: SB939
SB939 taken orally in a 4-week cycle.
Experimental: C
Myelodysplastic Syndrome
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

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: Throughout the study
Throughout the study

Secondary Outcome Measures

Outcome 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
Time Frame: Throughout the study
Throughout the study
To determine the dose limiting toxicities of SB939
Time Frame: Throughout the study
Throughout the study
To determine the pharmacokinetic profile of SB939
Time Frame: Throughout the study
Throughout the study
To assess histone acetylation in PBMC and other biomarkers
Time Frame: Throughout the study
Throughout the study
To document anti-tumor activity
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S*BIO

Investigators

  • Principal Investigator: George Wilding, M.D., University of Wisconsin, Madison
  • Principal Investigator: Boon Cher Goh, M.D., National University Hospital, Singapore
  • Principal Investigator: Han Chong Toh, M.D., National Cancer Center
  • Principal Investigator: Charles Chuah, M.D., Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB939-2006-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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