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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):
S*BIO

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 26, 2008
Last Update Posted Date April 23, 2012
Study Start Date  ICMJE April 2007
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
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, in patients with advanced malignancies. [ Time Frame: Throughout the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
  • 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 ]
  • To determine the dose limiting toxicities of SB939 [ Time Frame: Throughout the study ]
  • To determine the pharmacokinetic profile of SB939 [ Time Frame: Throughout the study ]
  • To assess histone acetylation in PBMC and other biomarkers [ Time Frame: Throughout the study ]
  • To document anti-tumor activity [ Time Frame: Throughout the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Hematologic Malignancies
  • Myelodysplastic Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Advanced solid tumors
    Intervention: Drug: SB939
  • Experimental: B
    Advanced hematologic malignancies
    Intervention: Drug: SB939
  • Experimental: C
    Myelodysplastic Syndrome
    Interventions:
    • Drug: SB939
    • Drug: Azacitidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2010)
85
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
60
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00741234
Other Study ID Numbers  ICMJE SB939-2006-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party S*BIO
Study Sponsor  ICMJE S*BIO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account S*BIO
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP