Clinical Trials /

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

NCT03773302

Description:

Infigratinib is an oral medication which selectively binds to fibroblast grown factor receptor (FGFR)-2 and is being developed to treat participants with FGFR-2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral Infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR-2 gene fusions/translocations.

Related Conditions:
  • Cholangiocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
  • 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

Clinical Trial IDs

  • ORG STUDY ID: QBGJ398-301
  • SECONDARY ID: 2018-004004-19
  • NCT ID: NCT03773302

Conditions

  • Advanced Cholangiocarcinoma
  • FGFR2 Gene Mutation

Interventions

DrugSynonymsArms
BGJ398InfigratinibInfigratinib (BGJ398) 125 mg
GemcitabineGemcitabine + Cisplatin
CisplatinGemcitabine + Cisplatin

Purpose

Infigratinib is an oral medication which selectively binds to fibroblast grown factor receptor (FGFR)-2 and is being developed to treat participants with FGFR-2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral Infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR-2 gene fusions/translocations.

Trial Arms

NameTypeDescriptionInterventions
Infigratinib (BGJ398) 125 mgExperimentalInfigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib
  • BGJ398
Gemcitabine + CisplatinActive ComparatorParticipants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
  • Gemcitabine
  • Cisplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed non-resectable, recurrent or metastatic
             cholangiocarcinoma. Participants with gallbladder cancer or ampullary carcinoma are
             not eligible

          -  Documented FGFR-2 gene fusions/translocations

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Able to swallow and retain oral medication

          -  Willingness to avoid pregnancy or father children

        Exclusion Criteria:

          -  Received treatment with any systemic anti-cancer therapy for unresectable, recurrent,
             or metastatic cholangiocarcinoma. Prior neoadjuvant or adjuvant therapy is permitted
             if completed > 6 months prior to first dose of study drug.

          -  History of a liver transplant

          -  Received prior or current treatment with a mitogen activated protein kinase kinase
             (MEK) or selective FGFR inhibitor

          -  Have impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled
             nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection.

          -  Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,
             parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis
             etc.

          -  History and/or current evidence of extensive tissue calcification including, but not
             limited to, the soft tissue, kidneys, intestine, myocardium and lung with the
             exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and
             asymptomatic coronary calcification

          -  Current evidence of corneal or retinal disorder/keratopathy

          -  Receiving and continued treatment with agents or consuming foods that are known strong
             inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus
             and/or calcium concentration

          -  Receiving and continued treatment with therapeutic doses of certain anticoagulants
             that are primarily metabolized by CYP3A4. (Alternative medications that are not
             metabolized by CYP3A4 (e.g., dabigatran, edoxaban) are allowed)

          -  Clinically significant or uncontrolled cardiac disease

          -  Recent (≤ 3 months) transient ischemic attack or stroke

          -  Severe hearing loss

          -  Severe neuropathy

          -  History of another primary malignancy within 3 years except adequately treated in-situ
             carcinoma of the cervix or non-melanoma skin cancer or other curatively treated
             malignancy that is not expected to require treatment

          -  Pregnant or breastfeeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with progression-free survival (Central Imaging Assessment)
Time Frame:Month 12
Safety Issue:
Description:Defined as the time from randomization until date of disease progression by central independent imaging assessment (Response Evaluation Criteria in Solid Tumors [RECIST] v. 1.1) or death, whichever occurs first.

Secondary Outcome Measures

Measure:Percentage of overall survival in participants treated with infigratinib versus gemcitabine with cisplatin
Time Frame:Month 12
Safety Issue:
Description:Defined as time from date of randomization until death due to any cause
Measure:Percentage of investigator assessed progression free survival in participants treated with infigratinib compared to gemcitabine and cisplatin
Time Frame:Month 12
Safety Issue:
Description:Defined as the time from randomization until date of disease progression by site investigator (RECIST v1.1) or death, whichever occurs first.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:QED Therapeutics, Inc.

Trial Keywords

  • cholangiocarcinoma
  • unresectable cholangiocarcinoma
  • metastatic cholangiocarcinoma
  • fibroblast growth factor receptor inhibitor
  • FGFR2
  • FGFR2 gene fusions/translocations
  • BGJ398

Last Updated