Status:
COMPLETED
Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this randomized, double-blind, placebo-controlled study is to determine the safety and efficacy of pracinostat compared to placebo when combined with azacitidine, and FDA approved treat...
Eligibility Criteria
Inclusion
- Voluntary written informed consent
- 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:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x the upper limit of normal (ULN) (≤5 x ULN for patients with hepatic metastases
- Total bilirubin ≤1.5 x ULN or total bilirubin of 2, whichever is higher
- Serum creatinine \<2 mg/dL, or creatinine clearance ≤1.5 x ULN
- 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
- Received any of the following within the specified time frame prior to administration of study medication:
- Any investigational agent within 14 days or 5 half-lives prior to first study treatment, whichever is longer
- 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)
- Hydroxyurea within 48 hours prior to first study treatment
- 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
- Major surgery within 4 weeks prior to first study treatment
- Patients that have not recovered from side effects of previous therapy
- Cardiopulmonary function exclusion:
- Current unstable arrhythmia requiring treatment
- History of symptomatic congestive heart failure (New York Heart Association Classes III or IV)
- History of myocardial infarction within 6 months of enrollment
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01873703
Start Date
June 1 2013
End Date
November 1 2016
Last Update
September 13 2018
Active Locations (24)
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1
Southern Cancer Center
Mobile, Alabama, United States, 36608
2
Scripps Cancer Center
La Jolla, California, United States, 92037
3
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
4
Florida Cancer Specialists South
Fort Myers, Florida, United States, 33916