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Report for Clinical Trial NCT03420079

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I, Multi-center, Open-label, Single-arm, Dose-escalation and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activities of FCN-411 Monotherapy in Advanced Non-small Cell Lung Cancer

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 study is to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of FCN-411 monotherapy in EGFR-positive mutation non-small cell lung cancer chinese patients. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the anti-tumor activities of FCN-411.

NCT03420079 Lung Cancer
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

1 Interventions

Name: FCN-411

Description: This is a five parts study to determine the pharmacokinetics of FCN-411 administered orally at five dose levels (4 mg Cohort 1、8mg Cohort 2、 16mg Cohort 3、24mg Cohort 4 and 32mg Cohort 5) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an EGFR TKI agent (+/- additional chemotherapy regimens).
Type: Drug
Group Labels: 5

fcn-411 16mg fcn-411 24mg fcn-411 32mg fcn-411 4mg fcn-411 8mg


Primary Outcomes

Description: Cmax of FCN-411 following single dose.

Measure: Cmax of FCN-411 following single dose.

Time: PK blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 120 hours post-dose.

Description: AUC of FCN-411 After Single Dosing.

Measure: AUC of FCN-411 following single dose.

Time: PK blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 120 hours post-dose.

Description: Cmax of FCN-411 After multiple dosing.

Measure: Cmax of FCN-411 following multiple dosing.

Time: The datas should be evaluated multiple times on the eighth day、fifteenth day of Cycle 1, first day、second day of Cycle 2. Each cycle is 21 days.

Description: AUC of FCN-411 After Multiple Dosing.

Measure: AUC of FCN-411 following multiple dosing.

Time: The datas should be evaluated multiple times on the eighth day、fifteenth day of Cycle 1, first day、second day of Cycle 2. Each cycle is 21 days.

Description: Tmax of FCN-411 following single dose.

Measure: Tmax of FCN-411 following single dose.

Time: PK blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 120 hours post-dose.

Description: Tmax of FCN-411 following multiple dosing.

Measure: Tmax of FCN-411 following multiple dosing.

Time: The datas should be evaluated multiple times on the eighth day、fifteenth day of Cycle 1, first day、second day of Cycle 2. Each cycle is 21 days.

Description: t1/2 of FCN-411 following single dose.

Measure: t1/2 of FCN-411 following single dose.

Time: PK blood samples are collected at pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 120 hours post-dose.

Description: t1/2 of FCN-411 following multiple dosing

Measure: t1/2 of FCN-411 following multiple dosing

Time: The datas should be evaluated multiple times on the eighth day、fifteenth day of Cycle 1, first day、second day of Cycle 2. Each cycle is 21 days.

Purpose: Other

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

3. 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 ) and T790M status by biopsy sample or optical microscopy. --- T790M ---

Exclusion Criteria: 1. Treatment with any of the following: 1. Treatment with an EGFR TKI within 14 days or about 5x half-life, whichever is the longer, of the first dose of study drug; 2. 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; 3. Major surgery within 4 weeks of the first dose of study treatment; 4. Systemic irradiation including whole brain irradiation; 5. Previously treated by EGFR-TKI for T790M (for example Osimertinib). --- T790M ---



HPO Nodes


HPO: