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Report for Clinical Trial NCT03046992

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.

NCT03046992 EGFR Gene Mutation

1 Interventions

Name: YH25448

Description: Dose Escalation: YH25448 20mg~320mg, PO Dose Expansion: YH25448 40mg~240mg, PO Dose Extension: Recommended Dose 240mg of YH25448

Type: Drug

YH25448


Primary Outcomes

Description: To assess the safety and tolerability profile of YH25448 by Common Terminology Criteria for Adverse Events (CTCAE) v4.03; vital signs (blood pressure, pulse, weight); laboratory parameters (clinical chemistry, hematology, urinalysis); physical examination; centrally reviewed electrocardiograms (ECGs), echocardiogram or multiple gated acquisition scan and performance status.

Measure: Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Time: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.

Description: Per Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR) (according to independent review), prior to progression or further anti-cancer therapy.

Measure: Objective Response Rate (ORR)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Secondary Outcomes

Description: Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT.

Measure: Duration of Response (DoR)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT.

Measure: Disease Control Rate (DCR)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT. Kaplan-Meier plots will be used to summarize the progression-free survival.

Measure: Progression-Free Survival (PFS)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.

Measure: Overall Survival (OS)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.

Measure: Tumor shrinkage

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.

Measure: Objective Intracranial Response Rate (OIRR)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.

Measure: Duration of Intracranial Response (DoIR)

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Description: To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1. Kaplan-Meier plots will be used to summarize the progression-free survival.

Measure: Intracranial Progression Free Survival (IPFS).

Time: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. --- T790M ---

In dose expansion phase, further safety, tolerability, pharmacokinetic(PK) and efficacy will be evaluated at each dose level(s) of dose escalation phase in NSCLC patients who progressed following prior EGFR TKIs treatment and harbouring confirmed T790M mutation. --- T790M ---



HPO Nodes