Phase II Randomized, Double-Blinded, Placebo-Controlled Study of Pracinostat in Combination w/ Azacitidine in Patients w/ Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk 2 or High Risk Myelodysplastic Syndrome (MDS)

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with previously untreated myelodysplastic syndrome (MDS).

The study is evaluating a new experimental drug called pracinostat as an addition to standard MDS treatment, azacitidine. The study is testing the safety and effectiveness of pracinostat when combined with azacitidine, compared to azacitidine alone.

Pracinostat is a pill taken by mouth. It has been shown in the laboratory to kill cancer cells, and animal studies show that pracinostat is active against many cancer cell types. Azacitidine is FDA-approved treatment for MDS. It is given by injections under the skin or by infusion to a vein.

Study participants will be randomly assigned to one of two treatment arms:                                             

  • Arm 1: azacitidine + pracinostat
  • Arm 2: azacitidine + placebo (a pill that looks like pracinostat but contains no medicine)

Treatment Plan:

  • Treatment cycles are 28 days
  • Participants will take pracinostat/placebo 3 times a week for 3 weeks, followed by 1 week of rest in each treatment cycle
  • Participants will receive azacitidine via injection or infusion for 7 days of each treatment cycle 

Participants will continue treatment as long as they are responding and not experiencing unacceptable side effects.

Disease Status and/or Stage

previously untreated myelodysplastic syndrome

Sponsor

MEI Pharma

Key Eligibility

  • Men and women age 18 and older
  • Diagnosed with MDS
  • Previously untreated
  • Detailed eligibility reviewed when you contact the study team

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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