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NCT04580121 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT04580121 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 59 participants.
The verdict
NCT04580121, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).
Interventions
- DRUG Dexamethasone
- DRUG Dasatinib
- DRUG Tocilizumab
- DRUG RO7283420
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04580121
The ClinicalTrials.gov registry entry for NCT04580121 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT04580121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04580121 about?
NCT04580121 is a clinical study titled "A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.". This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) ...
What is the current status of trial NCT04580121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2020-11-04. Estimated completion is 2023-08-09.
What interventions are being tested in trial NCT04580121?
The interventions under investigation include: Dexamethasone (DRUG), Dasatinib (DRUG), Tocilizumab (DRUG), RO7283420 (DRUG).
Who is sponsoring clinical trial NCT04580121?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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