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Report for Clinical Trial NCT04687423
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
A multicenter, open, single-arm phase I dose exploration and phase II extended study was
conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary
antitumor activity of FCN-011 in patients with advanced solid tumor (phase I) and NTRK fusion
positive advanced solid tumor (phase II)
NCT04687423 Advanced Solid Tumor
1 Interventions
Name: FCN-011
Description: FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached.
Type: Drug
Group Labels: 1 Experimental: phase I dose exploration
Primary Outcomes
Measure: To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) Time: 30 days
Measure: The recommended phase II dose for FCN-011 Time: From first dose up to 30 days after last dose
Measure: Overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 Time: Baseline up to approximately 1 year
Secondary Outcomes
Measure: To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug Time: From enrollment up to 30 days after last dose
Measure: the death of the last medicine occurred within 30 days of frequency and cause of death Time: From enrollment up to 30 days after last dose
Measure: The occurrence of treatment-emergent adverse events (TEAs) Time: From enrollment up to 30 days after last dose
Measure: To quantify the last time point with a quantifiable concentration (AUClast) of FCN-338 after administration as a single agen Time: 2 months
Measure: To measure the time to reach the highest plasma concentrations (Tmax) of FCN-338 after single agent administration Time: 2 months
Measure: To quantify the terminal half-life (T1/2) of FCN-338 after administration as a single agent Time: 2 months
Measure: To quantify the dose-dependent serum concentrations (Cmax) of FCN-338 as a single agent Time: 2 months
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There are 2 SNPs
SNPs
Patients with known drug-resistant mutations (including but not limited to NTRK1 G595R
and NTRK3 G623R) were excluded in phase II;
12. Women who are pregnant or breastfeeding. --- G595R ---
Patients with known drug-resistant mutations (including but not limited to NTRK1 G595R
and NTRK3 G623R) were excluded in phase II;
12. Women who are pregnant or breastfeeding. --- G595R --- --- G623R ---