NCT04087876

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

First QC Date

September 11, 2019

Last Update Submit

April 3, 2025

Conditions

Keywords

intrahepatic cholangiocarcinomaiCCAMetastatic cholangiocarcinomaFGFR genomic alterationbiliary cancerbile duct cancerliver cancer

Interventions

derazantinib will be administered orally

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

CholangiocarcinomaBiliary Tract NeoplasmsBile Duct NeoplasmsLiver Neoplasms

Interventions

derazantinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System DiseasesBile Duct DiseasesLiver Diseases

Study Officials

  • Manuel Häckl, MD

    Basilea Pharmaceutica International Ltd

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Last Updated

April 6, 2025

Record last verified: 2025-04