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NCT01378377 · ClinicalTrials.gov registry record · Phase 1
Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus
A Phase 1 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01378377: Clinical Trial Phase 1 study, sponsored by EMD Serono.
NCT01378377 is a Phase 1 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378377, a Phase 1 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The research trial is testing the experimental drug pimasertib and the drug Torisel, given together, in the treatment of advanced solid tumors. The primary purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug combination.
Primary Outcome
DLT was defined as any of the following toxicities graded as per National Cancer Institute (NCI) common terminology criteria for adverse events (NCI CTCAE v4.0) encountered within cycle 1 of treatment at any dose level and judged not to be related to the underlying disease or concomitant medications. A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation would expose subjects to unacceptable risk; any Grade \>=3 non-hematological toxicity e
Interventions
- DRUG Temsirolimus
- DRUG Pimasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-05-27 |
| Est. Completion | 2012-02-23 |
| Phase | Phase 1 |
Why NCT01378377 stopped before completion
NCT01378377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.
NCT01378377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378377 about?
NCT01378377 is a clinical study titled "Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus". The research trial is testing the experimental drug pimasertib and the drug Torisel, given together, in the treatment of advanced solid tumors. The primary purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug combination.
What is the current status of trial NCT01378377?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2011-05-27. Estimated completion is 2012-02-23.
What interventions are being tested in trial NCT01378377?
The interventions under investigation include: Temsirolimus (DRUG), Pimasertib (DRUG).
Who is sponsoring clinical trial NCT01378377?
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 NCT01378377's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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