A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy

Jiangsu HengRui Medicine Co., Ltd.0 sitesAugust 10, 2020

ConditionsIntrahepatic Cholangiocarcinoma

InterventionsFamitinib

DrugsFamitinib

Overview

Phase: Phase 2
Intervention: Famitinib
Conditions: Intrahepatic Cholangiocarcinoma
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Primary Endpoint: Objective response rate per RECIST 1.1
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.

Registry

clinicaltrials.gov

Start Date

August 10, 2020

End Date

February 10, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation and written informed consent;
•Aged 18-75 years (inclusive), males and females;
•Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
•FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
•At least one measurable lesion that has not been treated locally;
•ECOG score of 0-1;
•Expected survival ≥ 12 weeks;

Exclusion Criteria

•Presence of multiple factors affecting oral medications;
•Wounds unhealed over a long period of time, or fractures not completely healed;
•Known or suspected allergy to investigational drug or any drug related to this trial.
•Known cases of CNS(Central Nervous System) metastasis;
•Uncontrolled cardiac diseases or symptoms;
•Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
•Patients previously treated with FGFR inhibitors (such as erdafitinib)

Arms & Interventions

famitinib

Intervention: Famitinib

Outcomes

Primary Outcomes

Objective response rate per RECIST 1.1

Time Frame: up to 24 months

Secondary Outcomes

DOR(At pre-defined intervals from initial dose up to 24 months)
PFS(At pre-defined intervals from initial dose up to 24 months)
Plasma concentrations of famitinib and its N-desethyl metabolite(At pre-defined intervals from initial dose up to 24 months)
DCR(At pre-defined intervals from initial dose up to 24 months)
OS(At pre-defined intervals from initial dose up to 24 months)
Adverse events (AE) and serious adverse event (SAE)(At pre-defined intervals from initial dose up to 24 months)