Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04087876 |
Expanded Access Status :
Available
First Posted : September 12, 2019
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment |
---|---|
Intrahepatic Cholangiocarcinoma | Drug: derazantinib |
Study Type : | Expanded Access |
Expanded Access Type : | Individual Patients |
See clinical trials of the intervention/treatment in this expanded access record. | |
Official Title: | Expanded Access Use of Derazantinib for Patients With Locally Advanced, Inoperable or Metastatic iCCA Harbouring FGFR Genomic Alterations |

- Drug: derazantinib
derazantinib will be administered orally

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087876
Contact: Frédérique Cantero, MD | +41768302499 | frederique.cantero@basilea.com | |
Contact: Stephan Braun, MD | +41616061225 | stephan.braun@basilea.com |
Responsible Party: | Basilea Pharmaceutica |
ClinicalTrials.gov Identifier: | NCT04087876 |
Other Study ID Numbers: |
DZB-iCCA-EA |
First Posted: | September 12, 2019 Key Record Dates |
Last Update Posted: | October 19, 2020 |
Last Verified: | October 2020 |
intrahepatic cholangiocarcinoma iCCA Metastatic cholangiocarcinoma FGFR genomic alteration |
biliary cancer bile duct cancer liver cancer |
Cholangiocarcinoma Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |