A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

Phase 2

Withdrawn

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Drug: Famitinib

• Registration Number: NCT04479904
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-21
• Study Start: 2020-08-10
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-22
• Primary Completion: 2021-12-10
• Study Completion: 2022-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
famitinib	Famitinib	-

Primary Outcome Measures

Name	Time	Method
Objective response rate per RECIST 1.1	up to 24 months

Secondary Outcome Measures

Name	Time	Method
DOR	At pre-defined intervals from initial dose up to 24 months	Duration of Response
PFS	At pre-defined intervals from initial dose up to 24 months	Progression-Free-Survival
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	Disease Control Rate
OS	At pre-defined intervals from initial dose up to 24 months	Overall survival
Adverse events (AE) and serious adverse event (SAE)	At pre-defined intervals from initial dose up to 24 months	Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug