Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome
NCT ID: NCT01873703
Last Updated: 2018-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2013-06-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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pracinostat plus azacitadine
60 mg of pracinostat by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days.
75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
pracinostat
Histone deacetylase inhibitor (HDACi)
Azacitidine
Active comparator 75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
Placebo with Azacitadine
Placebo by mouth 3 times a week for 3 weeks followed by 1 week of rest repeated every 28 days.
75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
Placebo
Placebo
Azacitidine
Active comparator 75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
Interventions
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pracinostat
Histone deacetylase inhibitor (HDACi)
Placebo
Placebo
Azacitidine
Active comparator 75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically documented diagnosis of MDS (any French-American-British \[FAB\] classification subtype; that is classified as intermediate 2 (1.5 to 2.0 points) or high risk (≥2.5 points) according to the International Prognostic Scoring System risk category, with \>5% and \<30% blasts, and a peripheral blast count of \<20,000
* Bone marrow aspirate smears and bone marrow biopsies within 28 days of first study treatment
* There must be a clinical indication for treatment with azacitidine.
* Previously untreated with hypomethylating agents (prior therapy with transfusions, hematopoietic growth factors, or immunosuppressive therapy is allowed)
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2
* Adequate organ function as evidenced by:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x the upper limit of normal (ULN) (≤5 x ULN for patients with hepatic metastases
2. Total bilirubin ≤1.5 x ULN or total bilirubin of 2, whichever is higher
3. Serum creatinine \<2 mg/dL, or creatinine clearance ≤1.5 x ULN
4. QTcF interval ≤470 msec
* Female or male patients ≥18 years-of-age
* Male patients who are surgically sterile or willing to use adequate contraceptive measures or abstain from heterosexual intercourse during the entire study treatment period
* Female patients who are surgically sterile or post menopausal or female patients who are not of child-bearing potential and female patients of child-bearing potential who agree to use adequate contraceptive measures or abstain from intercourse during the study treatment period, who are not breastfeeding, and who have had a negative serum pregnancy test ≤7 days prior to first study treatment.
* Willingness and ability to comply with the trial and follow-up procedures
Exclusion Criteria
1. Any investigational agent within 14 days or 5 half-lives prior to first study treatment, whichever is longer
2. Previous therapy for malignancy within 21 days prior to first study treatment, including any chemotherapy, immunotherapy, biological or hormonal therapy (6 weeks for nitrosoureas or mitomycin C)
3. Hydroxyurea within 48 hours prior to first study treatment
4. Hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists at least 7 days (14 days for Aranesp) prior to study enrollment
5. Major surgery within 4 weeks prior to first study treatment
* Patients that have not recovered from side effects of previous therapy
* Cardiopulmonary function exclusion:
1. Current unstable arrhythmia requiring treatment
2. History of symptomatic congestive heart failure (New York Heart Association Classes III or IV)
3. History of myocardial infarction within 6 months of enrollment
4. Current unstable angina
* Concomitant treatment with histone deacetylase (HDAC) inhibitors or drugs with significant action as HDAC inhibitors, such as valproic acid, is not permitted
* Clinical evidence of central nervous system involvement
* Patients with gastrointestinal (GI) tract disease, causing the inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis).
* Active infection with HIV or chronic hepatitis B or C
* Life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study
* Presence of a malignant disease within the last 12 months, with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer
* Inability (including psychological, familial, sociological, or geographical conditions) to comply with trial and/or follow-up procedures
18 Years
ALL
No
Sponsors
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Helsinn Healthcare SA
INDUSTRY
Responsible Party
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Principal Investigators
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Guillermo Garcia-Manero, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Southern Cancer Center
Mobile, Alabama, United States
Scripps Cancer Center
La Jolla, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Florida Cancer Specialists South
Fort Myers, Florida, United States
Woodlands Medical Specialists
Pensacola, Florida, United States
Florida Cancer Specialists North
St. Petersburg, Florida, United States
Florida Cancer Specialist and Research Institute
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Indiana University Simon Cancer Ctr
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, Maryland, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan State University
Lansing, Michigan, United States
Nebraska Methodist
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Weill Cornell Medical Center
New York, New York, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States
Sarah Cannon Cancer Center, Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Related Links
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Sponsor website
Other Identifiers
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MEI-003
Identifier Type: -
Identifier Source: org_study_id
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