NCT00741234

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

4.9 years

First QC Date

August 22, 2008

Last Update Submit

April 19, 2012

Conditions

Solid TumorsHematologic MalignanciesMyelodysplastic Syndrome

Keywords

SB939Myelodysplastic SyndromeCombination with azacitidineSolid malignanciesHematologic malignanciesHDAC inhibitorRefractory to standard therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • To determine the dose limiting toxicities of SB939

    Throughout the study

  • To determine the pharmacokinetic profile of SB939

    Throughout the study

  • To assess histone acetylation in PBMC and other biomarkers

    Throughout the study

  • To document anti-tumor activity

    Throughout the study

Study Arms (3)

A

EXPERIMENTAL

Advanced solid tumors

Drug: SB939

B

EXPERIMENTAL

Advanced hematologic malignancies

Drug: SB939

C

EXPERIMENTAL

Myelodysplastic Syndrome

Drug: SB939Drug: Azacitidine

Interventions

SB939DRUG

SB939 taken orally in a 4-week cycle.

ABC
AzacitidineDRUG

Azacitidine taken orally with SB939 in a 4-week cycle

Also known as: Vidaza
C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Center

Singapore, 160610, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Hematologic NeoplasmsMyelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Guillermo Garcia-Manero, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 26, 2008

Study Start

April 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

US(2)SG(3)