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

Status
Completed
Cancer Type
Bile Duct Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03773302
Protocol IDs
QBGJ398-301 (primary)
2018-004004-19
NCI-2019-01025
Study Sponsor
QED Therapeutics

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

  1. Histologically or cytologically confirmed unresectable locally advanced or metastatic cholangiocarcinoma. Participants with gallbladder cancer or ampulla of Vater carcinoma are not eligible
  2. 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
  3. 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.
  4. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  5. Are able to swallow and retain oral medication
  6. Are willingness to avoid pregnancy or father children
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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.