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NCT03287245 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT03287245 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 27 participants.
The verdict
NCT03287245, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is an open-label, single-arm study of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV). The study will include two phases: initial phase and expansion phase. The initial phase will assess the safety and efficacy of idasanutlin monotherapy in ruxolitinib naïve and ruxolitinib-resistant or intolerant patients, respectively. If the initial phase shows promising results for ruxolitinib-resistant or intolerant patients, an expansion phase will be opened to further characterize the efficacy of idasanutlin.
Interventions
- DRUG Idasanutlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03287245
The ClinicalTrials.gov registry entry for NCT03287245 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 27 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 1 intervention - of which Idasanutlin is the first listed.
NCT03287245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03287245 about?
NCT03287245 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera". This is an open-label, single-arm study of idasanutlin monotherapy in participants with hydroxyurea (HU)-resistant/intolerant Polycythemia vera (PV). The study will include two phases: initial phase and expansion phase. The initial phase will assess the safety and efficacy of idasanutlin monotherapy...
What is the current status of trial NCT03287245?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2018-02-21. Estimated completion is 2020-03-03.
What interventions are being tested in trial NCT03287245?
The interventions under investigation include: Idasanutlin (DRUG).
Who is sponsoring clinical trial NCT03287245?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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