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NCT03230318 · ClinicalTrials.gov registry record · Phase 2
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT03230318: Completed Phase 2 study, sponsored by Basilea Pharmaceutica.
NCT03230318 is a Phase 2 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230318, a Phase 2 study, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study Summary
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazantinib capsules.
Primary Outcome
ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded independent central review using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1
Interventions
- DRUG derazantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2022-10-25 |
| Phase | Phase 2 |
What the finished NCT03230318 record still lists
NCT03230318 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 1 intervention - of which derazantinib is the first listed.
NCT03230318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03230318 about?
NCT03230318 is a clinical study titled "Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma". This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic therapy. Patients received an oral once-daily total dose of 300 mg derazan...
What is the current status of trial NCT03230318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2017-09-28. Estimated completion is 2022-10-25.
What interventions are being tested in trial NCT03230318?
The interventions under investigation include: derazantinib (DRUG).
Who is sponsoring clinical trial NCT03230318?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03230318's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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