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- || FCN-411 / Fosun Pharma
P1 data, Clinical Trial,Phase I, Journal: A phase I study of FCN-411, a pan-HER inhibitor, in EGFR-mutated advanced NSCLC after progression on EGFR tyrosine kinase inhibitors. (Pubmed Central) - Apr 27, 2022
P1
The RP2D was defined as 8 mg once daily. Future studies are warranted.
- | FCN-411 / Fosun Pharma
Journal: A validated ultra-performance LC-MS/MS method for quantifying a novel oral EGFR inhibitor FCN-411 in human plasma. (Pubmed Central) - Dec 18, 2020
And it was demonstrated to be acceptable according to the guidelines for bioanalytical assay validation. The method was robust, sensitive and repeatable, and it is ready to be applied to measure FCN-411 in a Phase I clinical pharmacokinetic study.
- | FCN-411 / Fosun Pharma
Enrollment change, Monotherapy, Metastases: A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - Jul 15, 2020
P1, N=90, Recruiting, Sponsor: Ahon Pharmaceutical Co., Ltd.
The method was robust, sensitive and repeatable, and it is ready to be applied to measure FCN-411 in a Phase I clinical pharmacokinetic study. N=66 --> 90
- | FCN-411 / Fosun Pharma
Enrollment open, Trial completion date, Trial primary completion date, Monotherapy, Metastases: A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - Jul 13, 2020
P1, N=66, Recruiting, Sponsor: Ahon Pharmaceutical Co., Ltd.
N=66 --> 90 Not yet recruiting --> Recruiting | Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Jun 2018 --> Dec 2020
- | FCN-411 / Fosun Pharma
New P1 trial, Monotherapy, Metastases: A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation (clinicaltrials.gov) - Jan 18, 2019
P1, N=66, Not yet recruiting, Sponsor: Ahon Pharmaceutical Co., Ltd.