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NCT01016483 · ClinicalTrials.gov registry record · Phase 1
Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer
A Phase 1 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
NCT01016483: Completed Phase 1 study, sponsored by EMD Serono.
NCT01016483 is a Phase 1 study that has completed, run by EMD Serono. The registered enrollment target is 141 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01016483, a Phase 1 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
Study Summary
The research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts: Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC1936369B, when combined with gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. Phase II: Will assess the anti-tumor activity of MSC1936369B combined with gemcitabine compared to gemcitabine alone as first line treatment in subjects with metastatic pancreatic adenocarcinoma.
Primary Outcome
DLT using the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE) v3.0,was defined as any of the following toxicities at any dose level and judged to be possibly or probably related to trial medication by the Investigator and/or the Sponsor and relevant for the combination treatment: Grade 3/more non-hematological toxicity excluding: Subjects with liver involvement: Grade 4 asymptomatic increases in liver function tests and subject without liver involvement: Grade 3 a
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG Pimasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2009-11-30 |
| Est. Completion | 2015-04-30 |
| Phase | Phase 1 |
What the finished NCT01016483 record still lists
NCT01016483 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (135% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01016483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01016483 about?
NCT01016483 is a clinical study titled "Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer". The research trial is testing the experimental treatment MSC1936369B in combination with Gemcitabine, in subjects with metastatic pancreatic adenocarcinoma. The study will be run in two parts: Safety Run-In: Will determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose of MSC193...
What is the current status of trial NCT01016483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2009-11-30. Estimated completion is 2015-04-30.
What interventions are being tested in trial NCT01016483?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), Pimasertib (DRUG).
Who is sponsoring clinical trial NCT01016483?
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 NCT01016483's enrollment target sits among peer trials
141 401st of 2000 higher than 1,599 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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