Status:
UNKNOWN
A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation
Lead Sponsor:
Ahon Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I trial with dose-escalation stage and dose-expansion stage is the first-in-human study of FCN-411, a drug being developed for treatment of advanced cancers. The initial purpose of the stud...
Detailed Description
This is a multicenter, open, single arm phase I clinical trial to explore the dose of FCN-411 in advanced lung cancer patients with disease progression after standard treatment or unsuitable for stand...
Eligibility Criteria
Inclusion
- Age 18 years and older.
- Histological or cytological confirmed diagnosed advanced or metastatic NSCLC.
- Documentation of disease progression while on previous continuous treatment with first-line EGFR TKI; patients must have confirmation of tumor EGFR activating mutations (exon 19 del, or exon 21 ins) and T790M status by biopsy sample or optical microscopy.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG).
- Have a life expectancy of at least 12 weeks.
- Have measurable disease based on RECIST v1.1. Note: previously irradiated not chosen, unless disease progression after irradiation.
- Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
- Neutrophils (absolute value) ≥ 1.5×10\^9/L;
- Hemoglobin ≥ 90 g/L;
- Platelet ≥ 90×10\^9/L;
- Serum total bilirubin ≤ 1.5× ULN（for Patients with Gilbert Syndrome, total bilirubin ≤ 3×ULN and bilirubin ≤ 1.5×ULN should be permitted）
- Aspartate aminotransferase、alanine aminotransferase ≤ 2.5×ULN; for patients with hepatic metastases, AST、ALT ≤ 5×ULN;
- Creatinine \< 1.5×ULN creatinine clearance rate≥ 45 mL/min (Cockcroft Gault for calculating)
- Female subjects have a negative urine or serum pregnancy.
Exclusion
- Treatment with any of the following:
- Treatment with an EGFR TKI within 14 days or about 5 half-lives, whichever is the longer, of the first dose of study drug;
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs for the treatment from a previous treatment regimen within 14 days of the first dose of study treatment;
- Major surgery within 4 weeks of the first dose of study treatment;
- Systemic irradiation including whole brain irradiation;
- Previously treated by EGFR-TKI for T790M (for example Osimertinib).
- P-glycoprotein inducers (for example Rifampicin) or inhibitors (for example ritonavir) are required during the study.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
- Meningeal metastases or CNS metastasis received intervention or malignancy related epilepsy; brain metastases without symptom are eligible.
- Any serious or uncontrolled systemic disease, including but not limited to:
- Uncontrolled hypertension;
- Active hemorrhage;
- Active infections including hepatitis B, or hepatitis C;
- Human immunodeficiency virus positive;
- Child Pugh C;
- Bullous or exfoliative skin diseases;
- Severe malnutrition;
- History of keratitis or ulcerative keratitis or dry eye;
- Uncontrolled large amount of third interstitial fluid retention;
- Other serious diseases or mental disorders or laboratory abnormalities.
- Cardiac function and disease are consistent with the following:
- QTc\> 470 milliseconds from 3 electrocardiograms (ECGs);
- Any clinically important abnormalities in rhythm;
- Any factors that increase the risk of QTc prolongation;
- Congestive heart failure ≥ grade 3 by New York Heart Association (NYHA);
- Previous history with interstitial lung disease、drug-induced interstitial lung disease or radiation pneumonitis require hormone therapy, or other active interstitial lung diseases required treatments.
- Lung function met one of the following criteria:
- Oxygen saturation ≤ 88%;
- The first second forced expiratory volume\< 50% of the predicted value;
- Diffusion capacity for CO \< 50% of the predicted value.
- Dysphagia, or active digestive system diseases or medical conditions potentially affect FCN-411 absorption.
- Hypersensitivity to FCN-411 or similar compounds or excipients.
- Pregnant or lactating women.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03420079
Start Date
August 1 2018
End Date
December 20 2021
Last Update
July 16 2020
Active Locations (1)
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1
Cancer hospital chinese academy fo medical scienced
Beijing, China, 100021