Unresectable Cholangiocarcinoma Metastatic Cholangiocarcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : INCB054828
INN of investigational material : Pemigatinib
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : P
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF). 2.Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual). 3.Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria. 4.Eastern Cooperative Oncology Group performance status 0 to 1. 5.Documented FGFR2 rearrangement. 6.Willingness to avoid pregnancy or fathering children.
Exclusion criteria
Exclusion criteria: 1.Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin the start of study drug (Cycle 1 Day 1) must be at least 14 days and = 300/micro L, undetectable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months. 16.Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited 17.Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients. 18.Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy PFS:defined as the time from date of randomization until date of disease progression (according to RECIST v1.1 and assessed by an ICR) or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1.ORR (CR + PR): defined as the proportion of participants with best overall response of CR or PR per RECIST v1.1 as assessed by an ICR. 2.OS:defined as the time from date of randomization until death due to any cause. 3.Duration of response: Defined as the time from the date of the first assessment of CR or PR until the date of the first disease progression by an ICR per RECIST v1.1 or death, whichever occurs first. 4.Disease control rate: Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease (SD) per RECIST v1.1 as assessed by an ICR. 5.Number of treatment-emergent adverse events: Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. 6.Quality of Life impact as assessed by the EQ-5D-3L questionnaire 7.Quality of Life impact as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire 8.Quality of Life impact as assessed by the EORTC QLQ-BIL21 questionnaire | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed