Trials / Terminated
TerminatedNCT04623996
A Study of TP-0184 to Treat Anemia in Adults With IPSS-R Low or Intermediate Risk MDS
A Phase 1/2, Open-Label Clinical Study To Evaluate Safety And Efficacy Of TP-0184 To Treat Anemia When Administered To Adult Patients With IPSS-R Low Or Intermediate Risk Myelodysplastic Syndromes
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TP-0184 | Oral dose |
Timeline
- Start date
- 2020-12-28
- Primary completion
- 2021-04-27
- Completion
- 2021-04-27
- First posted
- 2020-11-10
- Last updated
- 2023-11-09
- Results posted
- 2023-03-30
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04623996. Inclusion in this directory is not an endorsement.