Back to resultsA Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Famitinib
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
famitinib
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate per RECIST 1.1
Secondary Outcome Measures
DOR
Duration of Response
DCR
Disease Control Rate
PFS
Progression-Free-Survival
OS
Overall survival
Adverse events (AE) and serious adverse event (SAE)
Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
Plasma concentrations of famitinib and its N-desethyl metabolite
Full Information
NCT ID
NCT04479904
First Posted
July 17, 2020
Last Updated
June 16, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04479904
Brief Title
A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
It is difficult to screening subject
Study Start Date
August 10, 2020 (Anticipated)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
famitinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Famitinib
Intervention Description
po
Primary Outcome Measure Information:
Title
Objective response rate per RECIST 1.1
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
DOR
Description
Duration of Response
Time Frame
At pre-defined intervals from initial dose up to 24 months
Title
DCR
Description
Disease Control Rate
Time Frame
At pre-defined intervals from initial dose up to 24 months
Title
PFS
Description
Progression-Free-Survival
Time Frame
At pre-defined intervals from initial dose up to 24 months
Title
OS
Description
Overall survival
Time Frame
At pre-defined intervals from initial dose up to 24 months
Title
Adverse events (AE) and serious adverse event (SAE)
Description
Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
Time Frame
At pre-defined intervals from initial dose up to 24 months
Title
Plasma concentrations of famitinib and its N-desethyl metabolite
Time Frame
At pre-defined intervals from initial dose up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
Learn more about this trial
A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
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