5442W-13: MDS 14

CRC 13093: A Phase II Randomized, Double-Blinded, Placebo-Controlled Study of Pracinostat plus Azacitidine in Patients with Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk 2 or High-Risk Myelodysplastic Syndrome (MDS)

Type of Study
Cancer (Oncology) - Myelodysplastic Syndrome (MDS)
Location
Swedish Cancer Institute
Short Description
Purpose: 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 treatment for Myelodysplastic Syndrome (MDS).
Status
Open to Enrollment
Principal Investigator
Michael Milder, M.D.
Eligibility Notes
  • 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
  • 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
  • Must not 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
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org