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NCT01202877 · ClinicalTrials.gov registry record · Phase 1
PKC412 and 5-Azacytidine
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01202877: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01202877 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01202877, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the combination of PKC412 (also called Midostaurin) and 5-azacytidine can help to control refractory or relapsed acute leukemia and MDS. The safety and best dose of the combination of the drugs will also be studied.
Primary Outcome
Criteria for response per international working group for Myelodysplastic Syndrome (MDS) \& acute myeloid leukemia (AML) where responders obtained a complete remission (CR), a CR with incomplete bone marrow recovery (CRi), a morphologic leukemia-free status (MLFS), or a partial remission (PR). CR: \<5% bone marrow blasts, neutrophil count\>1.0 X10⁹/L, \& platelet count\>100 X10⁹/L. CRi: all CR criteria except residual neutropenia (\<1.0 X10⁹/L) or thrombocytopenia (\<100 X10⁹/L). MLFS: \<5% blas
Interventions
- DRUG 5-azacytidine
- DRUG PKC412
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01202877 record still lists
NCT01202877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which 5-azacytidine is the first listed.
NCT01202877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01202877 about?
NCT01202877 is a clinical study titled "PKC412 and 5-Azacytidine". The goal of this clinical research study is to learn if the combination of PKC412 (also called Midostaurin) and 5-azacytidine can help to control refractory or relapsed acute leukemia and MDS. The safety and best dose of the combination of the drugs will also be studied.
What is the current status of trial NCT01202877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2011-03. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01202877?
The interventions under investigation include: 5-azacytidine (DRUG), PKC412 (DRUG).
Who is sponsoring clinical trial NCT01202877?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01202877's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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