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NCT01842646 · ClinicalTrials.gov registry record · Phase 2
Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS)
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01842646: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01842646 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842646, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study is being done to see how safe an investigational drug is and test how well it will work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
Primary Outcome
Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10\^9/L, Neutrophils ≥ 1.0 x 10\^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pret
Interventions
- DRUG PF-04449913
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-08-29 |
| Est. Completion | 2021-06-10 |
| Phase | Phase 2 |
What the finished NCT01842646 record still lists
NCT01842646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which PF-04449913 is the first listed.
NCT01842646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01842646 about?
NCT01842646 is a clinical study titled "Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS)". This study is being done to see how safe an investigational drug is and test how well it will work to help people with refractory/relapsed myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
What is the current status of trial NCT01842646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2013-08-29. Estimated completion is 2021-06-10.
What interventions are being tested in trial NCT01842646?
The interventions under investigation include: PF-04449913 (DRUG).
Who is sponsoring clinical trial NCT01842646?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01842646's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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