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Expanded Access Use of Derazantinib for Advanced Intrahepatic Cholangiocarcinoma (iCCA) With FGFR Genomic Alterations

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 : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

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.

Condition or disease Intervention/treatment
Intrahepatic Cholangiocarcinoma Drug: derazantinib

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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



Intervention Details:
  • Drug: derazantinib
    derazantinib will be administered orally

Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Contacts
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Contact: Frédérique Cantero, MD +41768302499 frederique.cantero@basilea.com
Contact: Stephan Braun, MD +41616061225 stephan.Braun@basilea.com

Sponsors and Collaborators
Basilea Pharmaceutica
Additional Information:
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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: September 13, 2019
Last Verified: September 2019
Keywords provided by Basilea Pharmaceutica:
intrahepatic cholangiocarcinoma
iCCA
Metastatic cholangiocarcinoma
FGFR genomic alteration
biliary cancer
bile duct cancer
liver cancer
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms