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

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ClinicalTrials.gov Identifier: NCT04087876
Expanded Access Status : Available
First Posted : September 12, 2019
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Study Description
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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

Study Design
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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

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: derazantinib
    derazantinib will be administered orally
Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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: Inessa Polyakova, MD +41 76 682 3147 Inessa.Polyakova@basilea.com
Contact: Marc Engelhardt, MD +41 61 567 15 46

Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
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Study Director: Inessa Polyakova, MD Basilea Pharmaceutica International Ltd
More Information
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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: July 21, 2022
Last Verified: July 2022
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