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NCT03761069 · ClinicalTrials.gov registry record · Phase 1
Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias
A Phase 1 study, sponsored by PTC Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03761069 is a Phase 1 study that was terminated before completion, run by PTC Therapeutics. The registered enrollment target is 33 participants.
The verdict
NCT03761069, a Phase 1 study, was terminated before completion, sponsored by PTC Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics (PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite, O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia (AML) who have exhausted standard available therapies known to provide clinical benefit. The study is designed as a series of cohort-based dose escalations. For each cohort, a minimum of 3 evaluable participants with PK and safety data will be assessed. Additional participants will be recruited if additional PK data are needed to assess mean exposure based on the observed variability.
Interventions
- DRUG PTC299
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2021-12-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03761069
The ClinicalTrials.gov registry entry for NCT03761069 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PTC Therapeutics, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PTC299 is the first listed.
NCT03761069 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03761069 about?
NCT03761069 is a clinical study titled "Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias". This is an open-label, non-randomized, Phase 1b study to evaluate the safety, pharmacokinetics (PK) profiles, and preliminary evidence of antitumor activity of PTC299 and the metabolite, O-desmethyl PTC299, in participants with relapsed/refractory acute myeloid leukemia (AML) who have exhausted stan...
What is the current status of trial NCT03761069?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2018-10-29. Estimated completion is 2021-12-28.
What interventions are being tested in trial NCT03761069?
The interventions under investigation include: PTC299 (DRUG).
Who is sponsoring clinical trial NCT03761069?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
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