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NCT02988440 · ClinicalTrials.gov registry record · Phase 1
Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02988440: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02988440 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02988440, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.
Primary Outcome
Incidence and severity of AEs and SAEs, including changes in laboratory vital signs and ECGs
Interventions
- DRUG Sorafenib
- DRUG PDR001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2020-02-27 |
| Phase | Phase 1 |
What the finished NCT02988440 record still lists
NCT02988440 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Sorafenib is the first listed.
NCT02988440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02988440 about?
NCT02988440 is a clinical study titled "Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients". A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.
What is the current status of trial NCT02988440?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2017-04-20. Estimated completion is 2020-02-27.
What interventions are being tested in trial NCT02988440?
The interventions under investigation include: Sorafenib (DRUG), PDR001 (DRUG).
Who is sponsoring clinical trial NCT02988440?
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 NCT02988440's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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