Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
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|ClinicalTrials.gov Identifier: NCT02469415|
Recruitment Status : Terminated (FDA Clinical Hold)
First Posted : June 11, 2015
Results First Posted : April 23, 2018
Last Update Posted : October 16, 2018
The goal of this clinical research study is to learn if pacritinib, either alone or in combination with azacitidine or decitabine, can help to control MDS.
The safety of this drug and drug combination will also be studied.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Pacritinib Drug: 5-azacitidine Drug: Decitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes|
|Actual Study Start Date :||September 30, 2015|
|Actual Primary Completion Date :||June 3, 2017|
|Actual Study Completion Date :||June 3, 2017|
Experimental: Pacritinib + Azacitidine or Decitabine
Part 1: Pacritinib 200 mg taken by mouth twice daily. Study cycles administered every 28 days.
Part 2: After 4 cycles of treatment, Pacritinib combined with 5-azacitidine or Decitabine. Pacritinib decreased to 200 mg in morning and 100 mg in evening for first cycle of combined therapy with Pacritinib increased to 200 mg twice a day on subsequent cycles of combined therapy. Those with disease progression prior to 4 cycles of Pacritinib may initiate Pacritinib + HMA study portion prior to completion of 4 cycles. Starting dose of either 5-azacitidine 75 mg/m2 by vein (IV) or Decitabine 20 mg/m2 IVon Days 1 - 5 of Cycles 5 and beyond.
Part 1: Pacritinib 200 mg taken by mouth twice daily.
Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined therapy.
Part 2 Starting Dose of 5-azacitidine: 75 mg/m2 by vein on Days 1 - 5 of Cycles 5 and beyond.
Part 2 Starting Dose of Decitabine: 20 mg/m2 by vein on on Days 1 - 7 of Cycles 5 and beyond.
Other Name: Dacogen
- Overall Response Rate (ORR) [ Time Frame: 28 days ]The primary efficacy outcome of both parts is the overall response rate (ORR) based mainly on hematologic improvement defined by (International Working Group) IWG-2006 criteria, and which also includes complete remission (CR), partial remission (PR) and marrow complete remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469415
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Courtney DiNardo, MD||M.D. Anderson Cancer Center|