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NCT00957580 · ClinicalTrials.gov registry record · Phase 2
Trial of Pimasertib in Hematological Malignancies
A Phase 2 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT00957580: Clinical Trial Phase 2 study, sponsored by EMD Serono.
NCT00957580 is a Phase 2 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957580, a Phase 2 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts: Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies. Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.
Primary Outcome
The DLT was any toxicity that resulted in treatment delay for more than (\>) 2 weeks due to treatment-related adverse effects, or any Grade greater than or equal to (\>=) 3 non-hematological toxicity excluding Grade 4 asymptomatic increases in liver function tests reversible within 7 days in subjects with liver involvement, and Grade 3 asymptomatic increases in liver function tests reversible within 7 days for subjects without liver involvement, Grade 3 vomiting unless encountered and persistent
Interventions
- DRUG Pimasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2009-09-30 |
| Est. Completion | 2012-12-31 |
| Phase | Phase 2 |
Why NCT00957580 stopped before completion
NCT00957580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 1 intervention - of which Pimasertib is the first listed.
NCT00957580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957580 about?
NCT00957580 is a clinical study titled "Trial of Pimasertib in Hematological Malignancies". This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts: Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological...
What is the current status of trial NCT00957580?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2009-09-30. Estimated completion is 2012-12-31.
What interventions are being tested in trial NCT00957580?
The interventions under investigation include: Pimasertib (DRUG).
Who is sponsoring clinical trial NCT00957580?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00957580's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 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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