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

NCT00741234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2012-04-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SB939

SB939 taken orally in a 4-week cycle.

DRUG

Azacitidine

Azacitidine taken orally with SB939 in a 4-week cycle

Sponsors & Collaborators

  • S*BIO

    lead INDUSTRY

Principal Investigators

  • George Wilding, M.D. · University of Wisconsin, Madison

  • Boon Cher Goh, M.D. · National University Hospital, Singapore

  • Han Chong Toh, M.D. · National Cancer Center

  • Charles Chuah, M.D. · Singapore General Hospital

  • Guillermo Garcia-Manero, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741234 on ClinicalTrials.gov