Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia
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|ClinicalTrials.gov Identifier: NCT02730884|
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : November 6, 2018
The goal of this clinical research study is to learn if rigosertib can help to control MF in patients with anemia. The safety of this drug will also be studied.
This is an investigational study. Rigosertib is not FDA-approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 35 participants will be enrolled in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelofibrosis Anemia Splenomegaly||Drug: Rigosertib Behavioral: Questionnaire||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia|
|Actual Study Start Date :||August 16, 2017|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Participants receive oral Rigosertib under fasting conditions twice a day on a continuous basis. Quality of life questionnaire completed on Day 1 of Cycle 1.
Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.
Other Name: ON 01910.Na
Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete.
Other Name: Survey
- Change in Spleen Volume [ Time Frame: Baseline and 48 weeks ]Spleen response defined as ≥ 35% spleen volume reduction from Baseline, which must be confirmed by MRI or CT measurement per revised International Working Group for Myelofibrosis Research and Treatment (IWG MRT) response criteria.
- Change in Anemia Response [ Time Frame: Baseline and 48 weeks ]Anemia response defined as the proportion of transfusion-independent patients with Hgb increase of at least 2 g/dL from Baseline or the proportion of transfusion-dependent patients becoming transfusion independent for at least 12 weeks as defined in 2013 International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria.
- Symptoms Response [ Time Frame: 48 weeks ]Symptoms response defined as the proportion of patients achieving ≥ 50% reduction in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at any time before Week 48.
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): NCT02730884
|Contact: Jorge Cortes, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Cortes, MD||M.D. Anderson Cancer Center|