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)
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).
January 01, 1900
Cancer () - Myelodysplastic Syndrome (MDS)
Michael Milder, M.D.
Swedish Cancer Institute
- 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 2...