Back to resultsExpanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
derazantinib
Sponsored by
About this trial
This is an expanded access trial for Intrahepatic Cholangiocarcinoma focused on measuring intrahepatic cholangiocarcinoma, iCCA, Metastatic cholangiocarcinoma, FGFR genomic alteration, biliary cancer, bile duct cancer, liver cancer
Eligibility Criteria
Inclusion Criteria:
- all other treatment options have been exhausted
- patient is ineligible for any ongoing trials or is geographically inaccessible to trials including an ongoing trial with derazantinib
- there is reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
- patient is willing and able to provide written informed consent
- if applicable, regulatory approval by the appropriate jurisdiction is obtained
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04087876
Brief Title
Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
Official Title
Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica
4. Oversight
5. Study Description
Brief Summary
Basilea is providing expanded access to derazantinib for patients with locally advanced, inoperable or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR genomic alterations on a patient by patient basis while clinical development of derazantinib is ongoing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
intrahepatic cholangiocarcinoma, iCCA, Metastatic cholangiocarcinoma, FGFR genomic alteration, biliary cancer, bile duct cancer, liver cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
derazantinib
Intervention Description
derazantinib will be administered orally
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
all other treatment options have been exhausted
patient is ineligible for any ongoing trials or is geographically inaccessible to trials including an ongoing trial with derazantinib
there is reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
patient is willing and able to provide written informed consent
if applicable, regulatory approval by the appropriate jurisdiction is obtained
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Häckl, MD
Phone
+41 76 302 53 10
Email
manuel.haeckl@basilea.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Engelhardt, MD
Phone
+41 79 701 0551
Email
marc.engelhardt@basilea.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Häckl, MD
Organizational Affiliation
Basilea Pharmaceutica International Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://www.basilea.com/
Description
Basilea Website
URL
https://www.clinicaltrials.gov/ct2/show/NCT03230318?cond=derazantinib&rank=1
Description
CTgov link to ongoing study with derazantinib
Learn more about this trial
Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
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