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NCT03151408 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia
A Phase 3 study, sponsored by Helsinn Healthcare.
- Terminated
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT03151408 is a Phase 3 study that was terminated before completion, run by Helsinn Healthcare. The registered enrollment target is 406 participants.
The verdict
NCT03151408, a Phase 3 study, was terminated before completion, sponsored by Helsinn Healthcare.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the stu
Interventions
- DRUG Azacitidine
- DRUG Placebos
- DRUG Pracinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03151408
The ClinicalTrials.gov registry entry for NCT03151408 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 406 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT03151408 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03151408 about?
NCT03151408 is a clinical study titled "An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia". This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit...
What is the current status of trial NCT03151408?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2017-06-23. Estimated completion is 2020-08-20.
What interventions are being tested in trial NCT03151408?
The interventions under investigation include: Azacitidine (DRUG), Placebos (DRUG), Pracinostat (DRUG).
Who is sponsoring clinical trial NCT03151408?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
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