A Study of TP-0184 to Treat Anemia in Adults With IPSS-R Low or Intermediate Risk MDS
NCT04623996 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2023-11-09
Summary
This study will evaluate preliminary safety and efficacy of TP-0184 to treat anemia when administered to adult patients with Revised International Prognostic Scoring System (IPSS-R) low or intermediate risk MDS. The recommended Phase 2 dose (RP2D) will be determined by the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the Phase 1 portion of the study.
Conditions
- Anemia in Myelodysplastic Syndromes
Interventions
- DRUG
-
TP-0184
Oral dose
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-28
- Primary Completion
- 2021-04-27
- Completion
- 2021-04-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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