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NCT05744739 · ClinicalTrials.gov registry record · Phase 1
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Northwestern University.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05744739: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by Northwestern University.
NCT05744739 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 15 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05744739, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design. The starting dose of tomivosertib is 100mgdaily (doses 24 ± 2 hours apart), PO, self-administered with meals. The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the highest dose. There is one dose level below (dose level -1 = 100mg QD without a meal) that will be given if the de-escalation condition is met during dose finding. Upon completion of the phase 1 dose finding portion of the study, the recommended starting dose of tomivosertib for the subsequent combination with the other agents will be determined, as described in Section 4.3 and Section 8.0. Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle at the dose level assigned for that cohort.
Primary Outcome
The 'MPA' is defined as the minimum dose of tomivosertib tested in the phase 1 dose-finding portion of the trial that the isotonic estimate of dose-limiting toxicities (DLTs) is below or equal to the target DLT rate of 20% in phase 1 and biologic activity is observed. Whichever dose level is declared the MPA must have at least 6 patients treated at that level.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Tomivosertib
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-09-29 |
| Est. Completion | 2030-04-23 |
| Phase | Phase 1 |
What the registry record for NCT05744739 still lists
NCT05744739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05744739 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05744739 about?
NCT05744739 is a clinical study titled "Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)". Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design. The starting dose of tomivosertib is 100mgdaily (doses 24 ± 2 hours apart), PO, self-administered with meals. The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the ...
What is the current status of trial NCT05744739?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2023-09-29. Estimated completion is 2030-04-23.
What conditions does trial NCT05744739 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05744739?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Tomivosertib (DRUG).
Who is sponsoring clinical trial NCT05744739?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05744739 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05744739's enrollment target sits among peer trials
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