Clinical Trial Details

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

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Trial Information

Broad Health Condition Advanced Cholangiocarcinoma
FGFR2 Gene Mutation

Specific Health Condition


Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC,WA,

Hospital
Chris O'Brien Lifehouse Hospital
Blacktown Hospital
Royal Adelaide Hospital
St John of God Hospital Subiaco

Phase of TrialPhase 3

Trial summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor
(FGFR) 2 and is being developed to treat participants with FGFR2 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 locally advanced or metastatic cholangiocarcinoma
with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or
gemcitabine plus cisplatin.
Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  Histologically or cytologically confirmed unresectable locally advanced or metastatic
       cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma
       are not eligible

    -  Have written documentation of local laboratory or central laboratory determination of
       a known or likely activating FGFR2 fusion/rearrangement from a sample collected before
       randomization

    -  Have an archival tumor tissue sample available with sufficient tumor content for FGFR2
       fusion/rearrangement molecular testing by the central laboratory. However, if an
       archival tumor tissue sample is not available, or does not meet requirements for
       central testing a newly obtained (before randomization) tumor biopsy may be submitted
       instead. If a prestudy written documentation of FGFR2 fusion/rearrangement in tumor
       tissue is available from the central laboratory, an additional tumor sample does not
       need to be submitted.

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

    -  Are able to swallow and retain oral medication

    -  Are willingness to avoid pregnancy or father children

  Exclusion Criteria:

    -  Received treatment with any systemic anti-cancer therapy for unresectable locally
       advanced or metastatic cholangiocarcinoma, with following exceptions

         1. Prior neoadjuvant or adjuvant therapy is permitted if completed > 6 months after
            the last dose of neoadjuvant or adjuvant therapy.

         2. One cycle of gemcitabine-based chemotherapy for locally advanced or metastatic
            cholangiocarcinoma is permitted before randomization

    -  History of a liver transplant

    -  Received previously or currently is receiving 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, vascular system 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 or are planning to receive agents or consuming foods
       that are known moderate or strong inducers or inhibitors of CYP3A4 and medications
       which increase serum phosphorus and/or calcium concentration

    -  Clinically significant or uncontrolled cardiac disease

    -  Recent (= 3 months prior to first dose of study drug) 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

    -  Have known microsatellite instability-high (MSI-H) disease and the decision is made by
       the treating investigator that an alternative, non-study therapy is warranted
       according to standard of care.

    -  Have any known hypersensitivity to gemcitabine, cisplatin, calcium-lowering agents,
       infigratinib, or their excipients

    -  Have any contraindication to cisplatin or gemcitabine treatment according to local
       labeling or standard institutional practice.

    -  Have taken any Chinese herbal medicine or Chinese patent medicine treatments with
       anticancer activity within 14 days of the first dose of study drug.

    -  Have received a live vaccine within 30 days before the first dose of study drug or are
       planning to receive a live vaccine during participation in this study

Minimum age18 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: QED Therapeutics, Inc.

Trial websitehttps://clinicaltrials.gov/show/NCT03773302

Trial IDNCT03773302