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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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. 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.
Primary Outcome
The proportion of CR/CRi responses will be estimated (by cohort) by the number of CR/CRi responses divided by the total number of evaluable patients. 95% exact binomial confidence intervals will be computed. The frequency and relative frequency of individual response categories will also be computed. Best overall response over all cycles of study treatment will also be described using frequency and relative frequency of individual response categories.
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 |
What the finished NCT02129101 record still lists
NCT02129101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02129101 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02129101's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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