Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements (FOENIX-CCA3)
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|ClinicalTrials.gov Identifier: NCT04093362|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2019
Last Update Posted : February 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cholangiocarcinoma FGFR2 Gene Rearrangements||Drug: TAS-120 Drug: Cisplatin/Gemcitabine||Phase 3|
Study TAS-120-301 is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements. Eligible patients will be randomized on a 1:1 basis to the following study arms:
- Experimental Arm: Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.
Control Arm: On Days 1 and 8 of a 21-day cycle, patients will receive:
- Cisplatin 25 mg/m2 in 1000 mL 0.9% saline by intravenous (I.V.) infusion over 1 hour, followed by 500 mL 0.9% saline over 30 minutes; and
- Gemcitabine 1000 mg/m2 in 250-500 mL 0.9% saline by I.V. infusion over 30 minutes, beginning after completion of the cisplatin and saline infusions.
Patients in the Experimental Arm may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first. However, treatment may continue following PD per RECIST 1.1 if the patient is clinically stable and is considered by the Investigator to be deriving continued clinical benefit from futibatinib.
Patients in the Control Arm may receive gemcitabine-cisplatin chemotherapy for up to 8 cycles or until PD or other withdrawal criteria are met, whichever comes first. Patients who discontinue gemcitabine-cisplatin due to documented disease progression (by ICR) may receive treatment with futibatinib ("crossover"), if medically appropriate in the opinion of the Investigator and if criteria for futibatinib treatment are met.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3|
|Actual Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
TAS-120 tablets, oral; 21-day cycle
TAS-120 is an oral FGFR inhibitor
Other Name: Futibatinib
Active Comparator: Cisplatin/Gemcitabine
• On Days 1 and 8 of a 21-day cycle, patients will receive:
Cisplatin/Gemcitabine is currently 1st line standard of care
- PFS: defined as the time from date of randomization to the date of documentation of disease progression by ICR per RECIST (version 1.1, 2009) or date of death, whichever comes first. [ Time Frame: up to 12 months ]Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
- ORR [ Time Frame: up to12 months ]defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR.
- DCR [ Time Frame: up to 12 months ]defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on ICR.
- OS [ Time Frame: up to 12 months ]defined as the time from the date of randomization until the date of death due to any cause.
- PFS per Investigator assessment [ Time Frame: up to 12 months ]defined as the time from date of randomization to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
- Safety and Tolerability [ Time Frame: up to 12 months ]Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093362