Trials / Completed
CompletedNCT03230318
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This was a multi-center, open-label, single arm study which evaluated the anti-cancer activity of derazantinib in adult patients with inoperable or advanced iCCA in the following study population: Patients with inoperable or advanced iCCA and with fibroblast growth factor receptor 2 (FGFR2) fusions (Substudy 1) or FGFR2 mutations/amplifications (Substudy 2), treated with at least one prior regimen of systemic therapy. Derazantinib was supplied as 100 mg capsules. A dose of 300 mg once-daily (three capsules of 100 mg each) of derazantinib was administered orally to patients, 1 hour before, or 2 hours after, a meal.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | derazantinib | Derazantinib was administered orally at 300 mg once daily |
Timeline
- Start date
- 2017-09-28
- Primary completion
- 2022-10-25
- Completion
- 2022-10-25
- First posted
- 2017-07-26
- Last updated
- 2023-12-19
- Results posted
- 2023-12-19
Locations
41 sites across 11 countries: United States, Belgium, Canada, France, Germany, Ireland, Italy, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03230318. Inclusion in this directory is not an endorsement.