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Report for Clinical Trial NCT03452150

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase

This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.

NCT03452150 Advanced Non Small Cell Lung Cancer
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: D-0316

Description: If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined

Type: Drug

Daily oral dose of D-0316


Primary Outcomes

Description: Incidence of DLTs

Measure: Dose Limiting Toxicities (DLTs)

Time: Day 1 - Day 28

Description: Incidence of AEs

Measure: Adverse events

Time: Day 1 - Day 28

Description: Incidence of laboratory abnormalities

Measure: Laboratory results

Time: Day 1 - Day 28

Description: Incidence of vital sign abnormalities

Measure: Vital signs

Time: Day 1 - Day 28

Description: Incidence of ECG abnormalities

Measure: Electrocardiogram

Time: Day 1 - Day 28

Secondary Outcomes

Description: AUC: area under the plasma concentration versus time curve for D-0316

Measure: Pharmacokinetic: area under the plasma concentration versus time curve (AUC)

Time: Day 1 through 6, Cycle Day 1-Day 15

Description: Cmax: maximum plasma drug concentration of D-0316

Measure: Pharmacokinetic: maximum plasma drug concentration (Cmax)

Time: Day 1 through 6, Cycle Day 1-Day 15

Description: tmax: Time to reach the Cmax of D-0316

Measure: Pharmacokinetic: Time to reach the Cmax (Tmax)

Time: Day 1 through 6, Cycle Day 1-Day 15

Description: t1/2: apparent terminal half-life of D-0316

Measure: Pharmacokinetic: Apparent terminal half-life (t1/2)

Time: Day 1 through 6, Cycle Day 1-Day 15

Description: Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Measure: Antitumor activity

Time: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

- Confirmation that the tumour harbours an EGFR T790M mutation. --- 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
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1