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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S*BIO
ClinicalTrials.gov Identifier:
NCT00741234
First received: August 22, 2008
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Solid Tumors
Hematologic Malignancies
Myelodysplastic Syndrome
 Drug: SB939
Drug: Azacitidine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by S*BIO:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the dose limiting toxicities of SB939 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • To determine the pharmacokinetic profile of SB939 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To assess histone acetylation in PBMC and other biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To document anti-tumor activity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: April 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: S*BIO
ClinicalTrials.gov Identifier: NCT00741234     History of Changes
Other Study ID Numbers: SB939-2006-001
Study First Received: August 22, 2008
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration
Singapore: Health Sciences Authority

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
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site
 Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013