SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02500927

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase II Study of ASP8273 — An Open-Label, Study of the Oral Administration of ASP8273 in Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor-NaïvePatients With Non-Small Cell Lung Cancer Harboring EGFR Mutations

The purpose of this study is to determine the safety, the antitumor activity and the pharmacokinetics of ASP8273 in EGFR tyrosine kinase inhibitor (EGFR-TKI)-naïve patients with non-small cell lung cancer (NSCLC) harboring EGFR activating mutations.

NCT02500927 EGFR-TKI-naïve Patients With NSCLC Harboring EGFR Activating Mutations
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: ASP8273 Capsules

Description: oral

Type: Drug

ASP8273 group

Name: ASP8273 Capsules A

Description: oral

Type: Drug

ASP8273 group

Primary Outcomes

Measure: Safety assessed by AEs

Time: Up to 18 months

Measure: Safety assessed by Laboratory tests

Time: Up to 18 months

Measure: Safety assessed by Vital signs

Time: Up to 18 months

Measure: Safety assessed by Percutaneous oxygen saturation (SpO2)

Time: Up to 18 months

Measure: Safety assessed by Body weight

Time: Up to 18 months

Description: ECG: Electrocardiogram

Measure: Safety assessed by 12-lead ECG

Time: Up to 18 months

Measure: Safety assessed by Ophthalmologic examination

Time: Up to 18 months

Measure: Safety assessed by Chest X-ray examination

Time: Up to 18 months

Measure: Safety assessed by Chest computed tomography (CT) examination

Time: Up to 18 months

Measure: Safety assessed by ECOG Performance Status

Time: Up to 18 months

Secondary Outcomes

Description: The overall response rate is defined as the proportion of subjects whose best overall response is rated as Complete response (CR) or Partial Response (PR)among all analyzed subjects

Measure: Overall response rate

Time: Up to 18 months

Description: The disease control rate is defined as the proportion of subjects whose best overall response is rated as Complete response (CR), Partial Response (PR), or Stable disease (SD) among all analyzed subjects

Measure: Disease control rate

Time: Up to 18 months

Measure: Plasma concentrations of unchanged ASP8273

Time: Up to Day1 of Cycle 3
Purpose: Treatment

Single Group Assignment

There are 2 SNPs

SNPs

1 L858R

- Patients confirmed to have the deletion of exon 19 (del ex19), L858R, G719X, or L861Q mutation among the EGFR activating mutations (patients at the study site who are documented to have any of the above-stated EGFR activating mutations can be enrolled in the study). --- L858R ---

2 L861Q

- Patients confirmed to have the deletion of exon 19 (del ex19), L858R, G719X, or L861Q mutation among the EGFR activating mutations (patients at the study site who are documented to have any of the above-stated EGFR activating mutations can be enrolled in the study). --- L858R --- --- L861Q ---


HPO Nodes

HPO:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1