Trials / Completed
CompletedNCT04241549
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
A Phase 1 Study of Cusatuzumab Plus Azacitidine in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- OncoVerity, Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cusatuzumab | Cusatuzumab at a dose 20 milligram per kilogram (mg/kg) once every 2 weeks will be administered intravenously. |
| DRUG | Azacitidine | Azacitidine at a dose 75 milligram per square meters (mg/m\^2) will be administered subcutaneously or intravenously. |
Timeline
- Start date
- 2020-03-25
- Primary completion
- 2021-07-19
- Completion
- 2021-07-19
- First posted
- 2020-01-27
- Last updated
- 2023-08-09
Locations
5 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04241549. Inclusion in this directory is not an endorsement.