NCT05308264 · Rigel Pharmaceuticals
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
What this study is about
Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)
View original scientific description
Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)
Interventions
DRUG
R906289 Monosodium (R289 Na)
Drug: R906289 Monosodium (R289 Na) R906289 Monosodium (250mg PO qd, 250mg PO bid, 500 mg PO qd, 500 mg PO bid, 750 mg PO qd, split dose - 500 mg PO AM/250 mg PO PM)
Primary outcome measures
Safety and Tolerability
Time frame: 2 Year
* Incidence of adverse events (AEs) * Incidence of discontinuation or interruptions of R289 due to AEs * Incidence of dose limiting toxicities (DLTs)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient must be ≥ 18 years of age at the time of signing the informed consent.
- Must have definitive diagnosis of MDS with very low, low, or intermediate-1 risk (International Prognostic Scoring System (IPSS)-R ≤ 3.5) and ≤5% bone marrow myeloblasts.
- Must be relapsed, refractory/resistant, intolerant, or have inadequate response to therapies with known clinical benefits for MDS, such as EPOs, luspatercept, and HMAs(i.e., azacytidine or decitabine). Patients with del (5q) must have failed prior lenalidomide therapy.
- Symptomatic anemia untransfused with hemoglobin \< 9.0 g/dL and no RBC transfusion within 16 of registration or
- RBC transfusion dependent defined as receiving ≥ 2 units of packed red blood cells (PRBCs) within 8 weeks in the preceding 16 weeks for a hemoglobin \<9.0 g/dL.
- Exploratory Phase 1B Cohort: 1. Transfusion-dependent LR-MDS who are refractory or intolerant to, or are ineligible for ESAs. 2. No prior therapy with any approved or in
Where
- Los Angeles, California
- Orange, California
- Palo Alto, California
- Miami, Florida
- Miami Beach, Florida
- St Louis, Missouri
- Hackensack, New Jersey
- New Brunswick, New Jersey
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2025 · Source of record for eligibility and locations