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NCT02129101 · ClinicalTrials.gov registry record · Phase 1
Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT02129101: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT02129101 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02129101, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or decitabine and so see how well they work in treating patients with myeloid malignancies. The hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo. Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with sonidegib or decitabine may be a safe and successful treatment for patients with myeloid malignancies.
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Azacitidine
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Sonidegib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2014-05 |
| Est. Completion | 2019-10-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02129101
The ClinicalTrials.gov registry entry for NCT02129101 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02129101 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02129101 about?
NCT02129101 is a clinical study titled "Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies". This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or decitabine and so see how well they work in treating patients with myeloid malignancies. The hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropri...
What is the current status of trial NCT02129101?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2014-05. Estimated completion is 2019-10-25.
What interventions are being tested in trial NCT02129101?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Azacitidine (DRUG), Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Sonidegib (DRUG).
Who is sponsoring clinical trial NCT02129101?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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