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NCT00780143 · ClinicalTrials.gov registry record · Phase 1
Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia
A Phase 1 study, sponsored by PharmaMar.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00780143: Clinical Trial Phase 1 study, sponsored by PharmaMar.
NCT00780143 is a Phase 1 study that was terminated before completion, run by PharmaMar. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00780143, a Phase 1 study, was terminated before completion, sponsored by PharmaMar.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
Primary Outcome
To determine the maximum tolerated dose (MTD) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.
Interventions
- DRUG Plitidepsin plus Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
Why NCT00780143 stopped before completion
NCT00780143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Plitidepsin plus Cytarabine is the first listed.
NCT00780143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00780143 about?
NCT00780143 is a clinical study titled "Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia". This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patient...
What is the current status of trial NCT00780143?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-11. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00780143?
The interventions under investigation include: Plitidepsin plus Cytarabine (DRUG).
Who is sponsoring clinical trial NCT00780143?
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 NCT00780143's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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