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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00741234
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Hematologic Malignancies Myelodysplastic Syndrome Drug: SB939 Drug: Azacitidine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine
U.S. FDA Resources

Arms and Interventions

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 Name: Vidaza


Outcome Measures

Primary Outcome Measures :
  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). [ Time Frame: Throughout the study ]

Secondary Outcome Measures :
  1. 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 ]
  2. To determine the dose limiting toxicities of SB939 [ Time Frame: Throughout the study ]
  3. To determine the pharmacokinetic profile of SB939 [ Time Frame: Throughout the study ]
  4. To assess histone acetylation in PBMC and other biomarkers [ Time Frame: Throughout the study ]
  5. To document anti-tumor activity [ Time Frame: Throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741234


Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Center
Singapore, Singapore, 160610
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
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
Principal Investigator: Guillermo Garcia-Manero, MD M.D. Anderson Cancer Center
More Information

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT00741234     History of Changes
Other Study ID Numbers: SB939-2006-001
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012

Keywords provided by S*BIO:
SB939
Myelodysplastic Syndrome
Combination with azacitidine
Solid malignancies
Hematologic malignancies
HDAC inhibitor
Refractory to standard therapy

Additional relevant MeSH terms:
Neoplasms
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors