Back to resultsA Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Primary Purpose
Solid Tumors, Hematologic Malignancies, Myelodysplastic Syndrome
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SB939
Azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring SB939, Myelodysplastic Syndrome, Combination with azacitidine, Solid malignancies, Hematologic malignancies, HDAC inhibitor, Refractory to standard therapy
Eligibility 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.
Sites / Locations
- MD Anderson Cancer Center
- University of Wisconsin-Madison
- National University Hospital
- National Cancer Center
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
Advanced solid tumors
Advanced hematologic malignancies
Myelodysplastic Syndrome
Outcomes
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).
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
To determine the dose limiting toxicities of SB939
To determine the pharmacokinetic profile of SB939
To assess histone acetylation in PBMC and other biomarkers
To document anti-tumor activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00741234
Brief Title
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S*BIO
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Hematologic Malignancies, Myelodysplastic Syndrome
Keywords
SB939, Myelodysplastic Syndrome, Combination with azacitidine, Solid malignancies, Hematologic malignancies, HDAC inhibitor, Refractory to standard therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Advanced solid tumors
Arm Title
B
Arm Type
Experimental
Arm Description
Advanced hematologic malignancies
Arm Title
C
Arm Type
Experimental
Arm Description
Myelodysplastic Syndrome
Intervention Type
Drug
Intervention Name(s)
SB939
Intervention Description
SB939 taken orally in a 4-week cycle.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
Vidaza
Intervention Description
Azacitidine taken orally with SB939 in a 4-week cycle
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To determine the dose limiting toxicities of SB939
Time Frame
Throughout the study
Title
To determine the pharmacokinetic profile of SB939
Time Frame
Throughout the study
Title
To assess histone acetylation in PBMC and other biomarkers
Time Frame
Throughout the study
Title
To document anti-tumor activity
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wilding, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Boon Cher Goh, M.D.
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Han Chong Toh, M.D.
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Chuah, M.D.
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Garcia-Manero, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Center
City
Singapore
ZIP/Postal Code
160610
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
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