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NCT04935359 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT04935359 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 511 participants.
The verdict
NCT04935359, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel could reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.
Interventions
- DRUG Placebo
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG NIS793
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2024-08-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04935359
The ClinicalTrials.gov registry entry for NCT04935359 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04935359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04935359 about?
NCT04935359 is a clinical study titled "Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2". The purpose of this study was to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). This study aimed to explore whether blockade of Transforming Gro...
What is the current status of trial NCT04935359?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2021-09-30. Estimated completion is 2024-08-13.
What interventions are being tested in trial NCT04935359?
The interventions under investigation include: Placebo (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), NIS793 (DRUG).
Who is sponsoring clinical trial NCT04935359?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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