Study Name
FIDES-01: A pivotal study of derazantinib in patients with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) and FGFR2 gene fusions or FGFR2 gene mutations or amplifications
ClinicalTrials.gov Identifier (if applicable)
NCT03230318
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
Please go to ClinicalTrials.gov to view participating study centers
Country
United States
Website
https://clinicaltrials.gov/ct2/show/NCT03230318
List additional Institutions (include address, phone number, and website)
Participating study centers are listed on ClinicalTrials.gov Go to: https://clinicaltrials.gov/ct2/show/NCT03230318
Study Contacts
Principal Investigator
Frédérique Cantero, MD
P.I. Phone
+41 76 830 2499
P.I. Email
frederique.cantero@basilea.com
Study Coordinator
Frédérique Cantero, MD
Study Coordinator Phone
+41 76 830 2499
Study Coordinator Email
frederique.cantero@basilea.com
List additional Study Coordinators (include phone number and email)
Stephan Braun, MD
+41 (0)79 121-1561
stephan.braun@basilea.com
OVERVIEW – in layman’s terms (150 words max)
FGFR2 genetic alterations (changes) are associated with different types of cancer. A drug that inhibits signaling through FGFR2 may be beneficial for treatment of these cancers. In a recent trial, patients with intrahepatic cholangiocarcinoma with a FGFR2 genetic alteration (a gene fusion) benefited the most from treatment with derazantinib.
Enrollment
target enrollment: 143
Study Start Date
11/10/2017
Estimated Completion Date
03/01/2021
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • The purpose of this study is to find out if derazantinib shows anti-cancer activity in persons with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors have an abnormal genetic form of the fibroblast growth factor receptor 2 gene, and whose tumor progressed after having received at least one prior systemic therapy (chemotherapy).
  • This study will continue to explore the safety profile of derazantinib.
Inclusion Criteria – Patients Must:
  • sign written informed consent
  • be 18 years of age or older
  • have advanced, inoperable or metastatic intrahepatic cholangiocarcinoma or mixed histology tumors (combined hepatocellular-cholangiocarcinoma), confirmed histologically or cytologically
  • have a genetic aberration of the fibroblast growth factor receptor 2 (FGFR2) gene, confirmed by genetic testing
  • have received at least one prior systemic therapy and then tumor progression, confirmed by radiography
  • ECOG performance status ≤ 1
  • Measurable disease by RECIST version 1.1 criteria
  • have adequate organ functions, indicated by laboratory values specific for liver, kidney and blood
  • not become pregnant and must use contraception
  • Please visit www.ClinicalTrials.gov, NCT03230318, for a comprehensive list of Inclusion Criteria
Exclusion Criteria – Patients Must NOT:
  • receive systemic anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy within four weeks before treatment with derazantinib
  • have surgery, locoregional or radiation therapy within 4 weeks before treatment with derazantinib
  • have received prior treatment with an inhibitor of fibroblast growth factor receptors
  • be unable to swallow capsules
  • have eye disorders (corneal or retinal disorder)
  • have disorders of the liver or gallbladder which are not under control
  • have a history of significant disorders of the heart
  • have abnormal blood levels of electrolytes (phosphate, potassium, calcium, magnesium)
  • have significant disorders of the stomach or gut (bowel) which could prevent the activity (efficacy) of derazantinib
  • have had previous malignancy (severe cancer which is not curated) within 2 years before treatment with derazantinib
  • pregnant or breast feeding
  • have a known hypersensitivity to derazantinib or other substance (excipient, vehicle, binding material) in the study drug
  • Please visit www.ClinicalTrials.gov, NCT03230318, for a comprehensive list of Exclusion Criteria
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • Genetic tests of tumor tissue will be required to test for FGFR2 genetic alteration (from a new biopsy taken or from stored tumor tissue from a previous biopsy)
  • Blood tests will also be required
POTENTIAL SIDE-EFFECTS – in layman’s terms
    • The most frequent side effects in cancer patients treated with derazantinib capsules as a single-agent (monotherapy), which occur in more than 5% of treated patients, are listed below. These side effects may be caused by derazantinib, but they may also be caused by other medications given at the same time, or by the underlying cancer.
    • Fatigue (extreme tiredness)
    • Asthenia (abnormal physical weakness or lack of energy)
    • Gastrointestinal effects such as nausea, vomiting, diarrhea, constipation, and dyspepsia
    • Dry mouth
    • Stomatitis (an inflamed and sore mouth)
    • Anemia (change in red blood cell count, decrease)
    • Changes in liver function tests (increase in alanine aminotransferase, aspartate aminotransferase, and/or alkaline phosphatase)
    • Change in blood creatinine level (increase)
    • Decrease (loss of) appetite
    • Dysgeusia (change in taste)
    • Dry skin
    • Eye effects such as:
      • Blurred vision (a lack of sharpness of vision resulting in the inability to see fine detail)
      • Dry Eye
      • Conjunctivitis, also known as pinkeye, is an infection of the conjunctiva (the front skin of the eye)
    • Alopecia (hair loss)