Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)

Conditions

• Low Risk Myelodysplastic Syndromes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• R906289 Monosodium (R289 Na) — DRUG
  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)

Study Details

Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)

Key Dates

Start date

Sep 12, 2022

Status verified

Oct 2025

Primary completion

Aug 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

86 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental
  ESCALATION PHASE: Dose Level 1: 250mg PO qd Dose Level 2: 500mg PO qd Dose Level 3: 750 mg PO qd Dose Level 4: 250 mg PO bid Dose Level 5: 500 mg PO AM/250 mg PO PM Dose Level 6: 500 mg PO bid EXPANSION PHASE (randomized 1:1): Dose Level 1: 250 mg PO qd Dose Level 2: 250 mg PO bid

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 2 Year ]

Central Contacts

• Strait Hicklin
  (650) 624-1100
  [email protected]

Locations (15)

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