PROOF : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractBile duct

Trial Overview Read MoreRead more

This phase 3 study is evaluating the effectiveness and safety of a targeted therapy (Infigratinib) in comparison with the standard of care chemotherapy (Gemcitabine plus Cisplatin) for treatment of patients with inoperable or metastatic cholangiocarcinoma.
 

This trial is treating patients with Cholangiocarcinoma.

This is a systemic therapy.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

QED Therapeutics, Inc.

Summary

Patients eligible to participate in this trial will receive daily oral doses of Infigratinib for three weeks of a 4 week cycle, or intravenous administration of Gemcitabine and Cisplatin on Day 1 and 8 of a 21 day cycle. Patients receiving Gemcitabine and Cisplatin, who experience cancer progression will be able to receive Infigratinib instead.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
GI Research Study Coordinator
gi.oncresearch@monashhealth.org
0436386758

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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