Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions (NCT02265341) | Clinical Trial Compass
CompletedPhase 2
Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions
United States12 participantsStarted 2014-12
Plain-language summary
This pilot phase II trial studies how well ponatinib hydrochloride works in treating patients with biliary cancer that has spread to other places in the body and that have alterations (fusions) in a gene known as fibroblast growth factor receptor 2 (FGFR2). Ponatinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological/cytological confirmation of biliary cancer
* Confirmation of advanced biliary cancer that is refractory or intolerant to gemcitabine or fluoropyrimidine based therapy with FGFR2 fusion \[using next-gen sequencing assays (such as Foundation One) or fluorescent in situ hybridization (FISH) break-apart assays\] or FGFR pathway mutation/amplification \[using next-gen sequencing assays (such as Foundation One)\]; assays must be performed in a Clinical Laboratory Improvement Amendments \[CLIA\] certified laboratory and done as a CLIA validated test or research use only \[RUO\] in a CLIA laboratory
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome
* Aspartate transaminase (AST) and alanine aminotransferase (ALT) \< 3 x ULN
* Creatinine =\< 1.5 x ULN
* Serum lipase and amylase =\< 2.5 x ULN; NOTE: if subject has tumor involvement in the liver =\< 3 x ULN
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Recovered from prior radiotherapy and/or systemic therapy related toxicities to grade =\< 1
* Provide informed written consent
* Life expectancy \>= 3 months
* Willing to return to enrolling institution for follow-up (during the Active Monitoring P…
What they're measuring
1
Clinical Benefit Rate (Percentage), Which Includes Confirmed Tumor Response (Complete Response [CR] or Partial Response [PR]) or Stable Disease (SD)