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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 is a Phase 1 study that has completed, run by EMD Serono. The registered enrollment target is 141 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01016483
The ClinicalTrials.gov registry entry for NCT01016483 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01016483 reports 0 study locations.
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.
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