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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

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:
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8