Clinical Trials Logo
  1. Home
  2. Intrahepatic Cholangiocarcinoma
  3. NCT03230318

Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma — FIDES-01  

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:
A Pivotal Study of Derazantinib in Patients With Inoperable or Advanced Intrahepatic Cholangiocarcinoma and FGFR2 Gene Fusions or FGFR2 Gene Mutations or Amplifications

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03230318
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Completed
Phase Phase 2
Start date September 28, 2017
Completion date October 25, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Completed NCT01938729 - Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma Phase 1
Recruiting NCT06239532 - HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05535647 - Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05009953 - Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT02254681 - Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC Phase 2
Active, not recruiting NCT01954745 - A Phase II Study of Cabozantinib (XL-184) Monotherapy in Patients With Advanced Cholangiocarcinoma After Progression on First or Second Line Systemic Therapy Phase 2
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05285358 - Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases Phase 1
Completed NCT03320980 - RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma N/A
Withdrawn NCT05019677 - GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC Phase 2
Withdrawn NCT03801499 - Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT05489692 - HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Recruiting NCT06101277 - Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG) N/A
Active, not recruiting NCT01917370 - VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway N/A
Withdrawn NCT01775280 - Response of Hepatic Tumors to Radioembolization Phase 2
Not yet recruiting NCT05342194 - Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Phase 3
Active, not recruiting NCT05781958 - Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC Phase 2