A Phase III Study of Infigratinib versus Gemcitabine/Cisplatin in People with Inoperable, Recurrent, or Metastatic Cholangiocarcinoma with FGFR2 Changes

Share
Print

Full Title

A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib versus Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations: The PROOF Trial (WIRB)

Purpose

In this study, researchers want to see if the investigational drug infigratinib improves the treatment of advanced cholangiocarcinoma (a tumor among the bile duct cancers) compared with the standard of care (chemotherapy with gemcitabine and cisplatin) in patients with an abnormality in a gene called FGFR2. Infigratinib may interfere with cancer cell growth by blocking the FGFR protein.

Patients in this study will be randomly assigned to receive infigratinib or gemcitabine/cisplatin. Patients who receive gemcitabine and cisplatin and whose cancer continues to grow can cross over to the infigratinib group. Infigratinib is taken orally (by mouth) and gemcitabine and cisplatin are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable, recurrent, or metastatic cholangiocarcinoma that contains an FGFR2 mutation.
  • Patients may not have received medical treatment for advanced cholangiocarcinoma. Prior therapy for earlier stage cancer, such as adjuvant treatment, must have been completed more than 6 months before entering the study.
  • Prior treatment with inhibitors of MEK or FGFR is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Protocol

19-364

Phase

III

Investigator

Co-Investigators

Diseases