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NCT03326310 · ClinicalTrials.gov registry record · Phase 1
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
A Phase 1 study of Chronic Myeloid Leukemia and Myelofibroses, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT03326310: Recruiting Phase 1 study of Chronic Myeloid Leukemia and Myelofibroses, sponsored by University of Chicago.
NCT03326310 is a Phase 1 study of Chronic Myeloid Leukemia and Myelofibroses that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 18 participants, below the 209-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03326310, a Phase 1 study of Chronic Myeloid Leukemia and Myelofibroses, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.
Primary Outcome
To determine the maximum tolerated dose (MTD) of selumetinib when combined with azacitidine and measure any toxicities that may arise.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Selumetinib
Study Locations (1)
Illinois
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2027-09-04 |
| Phase | Phase 1 |
What NCT03326310 shows while recruiting
NCT03326310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 209-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT03326310 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03326310 about?
NCT03326310 is a clinical study titled "Selumetinib and Azacitidine in High Risk Chronic Blood Cancers". This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A pa...
What is the current status of trial NCT03326310?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-09-04. Estimated completion is 2027-09-04.
What conditions does trial NCT03326310 study?
This clinical trial studies the following conditions: Chronic Myeloid Leukemia, Myelofibroses.
What interventions are being tested in trial NCT03326310?
The interventions under investigation include: Azacitidine (DRUG), Selumetinib (DRUG).
Who is sponsoring clinical trial NCT03326310?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03326310 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03326310's enrollment target sits among peer trials
18 30th of 35 higher than 6 of 35 other Chronic Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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