Intrahepatic CholangiocarcinomaNCT04087876
Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
A study testing derazantinib in people with Intrahepatic Cholangiocarcinoma, run by Basilea Pharmaceutica.
Trial summary
Basilea provided 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 was ongoing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- derazantinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
The following inclusion criteria were applied:
- all other treatment options had been exhausted
- patient was ineligible for any ongoing trials or was geographically inaccessible to trials including a trial with derazantinib
- there was a reason to believe that the potential benefit of receiving derazantinib outweighs the risk of treatment with an investigational drug product
- patient was willing and able to provide written informed consent
- if applicable, regulatory approval by the appropriate jurisdiction was obtained
About this study
Official title: Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations
Basilea provided 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 was ongoing.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- derazantinib
- Keywords
- intrahepatic cholangiocarcinoma, iCCA, Metastatic cholangiocarcinoma, FGFR genomic alteration, biliary cancer, bile duct cancer, liver cancer
- Medical subject headings
- Cholangiocarcinoma, Biliary Tract Neoplasms, Bile Duct Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
derazantinibDrug
derazantinib will be administered orally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Häckl, MD, Study director, Basilea Pharmaceutica International Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087876
- Sponsor's protocol ID
- DZB-iCCA-EA
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations
- ClinicalTrials.gov ID
- NCT04087876
- Acronym / sponsor ID
- DZB-iCCA-EA
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- intrahepatic cholangiocarcinoma, iCCA, Metastatic cholangiocarcinoma, FGFR genomic alteration, biliary cancer, bile duct cancer, liver cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basilea provided 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 was ongoing.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| derazantinibderazantinib will be administered orally | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Basilea WebsiteLink provided by the sponsor.
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Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Häckl, MD study director
Basilea Pharmaceutica International Ltd
Questions about this trial
What is this clinical trial studying?
A study testing derazantinib in people with Intrahepatic Cholangiocarcinoma, run by Basilea Pharmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.