Single-Arm Study of the Efficacy and Safety of Oral Rigosertib in Patients With Myelofibrosis (MF) and Anemia
NCT02730884 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2020-08-07
Summary
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.
Conditions
- Leukemia
- Myelofibrosis
- Anemia
- Splenomegaly
Interventions
- DRUG
-
Rigosertib
Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.
- BEHAVIORAL
-
Questionnaire
Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete.
Sponsors & Collaborators
-
Traws Pharma, Inc.
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Jorge Cortes, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-16
- Primary Completion
- 2019-08-22
- Completion
- 2019-08-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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