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NCT02325739 · ClinicalTrials.gov registry record · Phase 1
FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 172
- Enrollment target
NCT02325739: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02325739 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 172 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (187% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325739, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 172 participants
- Enrollment target
Study Summary
Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.
Primary Outcome
A dose-limiting toxicity 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 evaluation period of DLTs and met any of the criteria listed. The estimation of the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of the treatment was based upon the estimation of the probability of DLT during the evaluation period for subjects in the dose determining
Interventions
- BIOLOGICAL PDR001
- DRUG FGF401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2014-12-29 |
| Est. Completion | 2019-05-30 |
| Phase | Phase 1 |
What the finished NCT02325739 record still lists
NCT02325739 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (187% higher).
The record links to 0 conditions, and to 2 interventions - of which PDR001 is the first listed.
NCT02325739 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02325739 about?
NCT02325739 is a clinical study titled "FGF401 in HCC and Solid Tumors Characterized by Positive FGFR4 and KLB Expression". Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.
What is the current status of trial NCT02325739?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 172 participants. The study started on 2014-12-29. Estimated completion is 2019-05-30.
What interventions are being tested in trial NCT02325739?
The interventions under investigation include: PDR001 (BIOLOGICAL), FGF401 (DRUG).
Who is sponsoring clinical trial NCT02325739?
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 NCT02325739's enrollment target sits among peer trials
172 324th of 2000 higher than 1,677 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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