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A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedJune 22, 2021
July 1, 2020
1.3 years
July 17, 2020
June 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate per RECIST 1.1
up to 24 months
Secondary Outcomes (6)
DOR
At pre-defined intervals from initial dose up to 24 months
DCR
At pre-defined intervals from initial dose up to 24 months
PFS
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
- +1 more secondary outcomes
Study Arms (1)
famitinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 21, 2020
Study Start
August 10, 2020
Primary Completion
December 10, 2021
Study Completion
February 10, 2022
Last Updated
June 22, 2021
Record last verified: 2020-07