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

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623996 on ClinicalTrials.gov