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Pharmatech QBGJ398-301

Status:

Available | Phase III

Official 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

Study Purpose:

The PROOF Trial is a clinical research study to determine if the investigational drug, infigratinib, is an effective treatment for cholangiocarcinoma compared with the standard of care, chemotherapy gemcitabine with cisplatin, for patients with a genetic abnormality in the Fibroblast Growth Factor Receptor (FGFR) gene.

Interventions:

Arm 1: Infigratinib, study agent, (oral medication)

Arm 2: Gemcitabine with Cisplatin

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Advanced Cholangiocarcinoma

Marker Status:

FGFR-2 gene mutation

Eligibility:

Nonresectable, recurrent, metastatic, or advanced cholangiocarcinoma

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Pharmatech QBGJ398-301

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today