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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04935359 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 511 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
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 |
What the finished NCT04935359 record still lists
NCT04935359 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04935359 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04935359's enrollment target sits among peer trials
511 728th of 2000 higher than 1,272 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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