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NCT01314599 · ClinicalTrials.gov registry record · Phase 1
Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome
A Phase 1 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01314599: Completed Phase 1 study, sponsored by PharmaMar.
NCT01314599 is a Phase 1 study that has completed, run by PharmaMar. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01314599, a Phase 1 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183.
Primary Outcome
The recommended dose (RD) will be the immediate lower DL below the MTD (maximum tolerated dose)with less than 1/3 of the first 6 evaluable patients experiencing DLT (dose limiting toxicity)during the induction, provided the RD is ≥ dose level 2. If the RD is determined at dose level 1, no further expansion will be done, and the study will be terminated.
Interventions
- DRUG PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01314599 record still lists
NCT01314599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion is the first listed.
NCT01314599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01314599 about?
NCT01314599 is a clinical study titled "Clinical Study of PM01183 in Patients With Acute Leukemia or Relapsed/Refractory Myelodysplastic Syndrome". Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183.
What is the current status of trial NCT01314599?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2011-05. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01314599?
The interventions under investigation include: PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion (DRUG).
Who is sponsoring clinical trial NCT01314599?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01314599's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 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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