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RECRUITING Phase 1

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

NCT03326310 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Azacitidine
  • DRUG Selumetinib

Study Locations (1)

Illinois

  • The University of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2018-09-04
Est. Completion 2027-09-04
Phase Phase 1

Sponsor

University of Chicago

846 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03326310

The ClinicalTrials.gov registry entry for NCT03326310 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 846 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03326310 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03326310?

The interventions under investigation include: Azacitidine (DRUG), Selumetinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03326310?

This trial is sponsored by University of Chicago, which has 846 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial