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NCT01390818 · ClinicalTrials.gov registry record · Phase 1
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
NCT01390818: Completed Phase 1 study, sponsored by EMD Serono.
NCT01390818 is a Phase 1 study that has completed, run by EMD Serono. The registered enrollment target is 146 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01390818, a Phase 1 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
Study Summary
This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advanced or metastatic solid tumors. The primary purpose of the study is to determine the maximum tolerated dose of the drug combination.
Primary Outcome
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grad
Interventions
- DRUG MSC1936369B (pimasertib)
- DRUG SAR245409 (PI3K and mTOR inhibitor)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
What the finished NCT01390818 record still lists
NCT01390818 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 2 interventions - of which MSC1936369B (pimasertib) is the first listed.
NCT01390818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01390818 about?
NCT01390818 is a clinical study titled "Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors". This research trial is testing a combination of two experimental drugs, MSC1936369B (Mitogen-activated protein extracellular signal-regulated kinase (MEK) Inhibitor) and SAR245409 (Phosphatidylinositol 3-kinase (Pi3K)/Mammalian Target of Rapamycin (mTOR) inhibitor), in the treatment of locally advan...
What is the current status of trial NCT01390818?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2011-05. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01390818?
The interventions under investigation include: MSC1936369B (pimasertib) (DRUG), SAR245409 (PI3K and mTOR inhibitor) (DRUG).
Who is sponsoring clinical trial NCT01390818?
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 NCT01390818's enrollment target sits among peer trials
146 391st of 2000 higher than 1,610 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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