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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04479904
• Other study ID #: SHR-1020-II-204
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 10, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: July 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Famitinib
po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate per RECIST 1.1		up to 24 months
Secondary	DOR	Duration of Response	At pre-defined intervals from initial dose up to 24 months
Secondary	DCR	Disease Control Rate	At pre-defined intervals from initial dose up to 24 months
Secondary	PFS	Progression-Free-Survival	At pre-defined intervals from initial dose up to 24 months
Secondary	OS	Overall survival	At pre-defined intervals from initial dose up to 24 months
Secondary	Adverse events (AE) and serious adverse event (SAE)	Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug	At pre-defined intervals from initial dose up to 24 months
Secondary	Plasma concentrations of famitinib and its N-desethyl metabolite		At pre-defined intervals from initial dose up to 24 months