D-0316 First Time in Patients Ascending Dose Study

Advanced Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452150
• Other study ID #: XY-101
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2023
• Source: InventisBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 31, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses

• Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).

• Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.

• Confirmation that the tumour harbours an EGFR T790M mutation.

• No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.

• Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria:

• Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.

• Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• D-0316
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

Locations

Country	Name	City	State
China	Research Site	Changchun	Jilin
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities (DLTs)	Incidence of DLTs	Day 1 - Day 28
Primary	Adverse events	Incidence of AEs	Day 1 - Day 28
Primary	Laboratory results	Incidence of laboratory abnormalities	Day 1 - Day 28
Primary	Vital signs	Incidence of vital sign abnormalities	Day 1 - Day 28
Primary	Electrocardiogram	Incidence of ECG abnormalities	Day 1 - Day 28
Secondary	Pharmacokinetic: area under the plasma concentration versus time curve (AUC)	AUC: area under the plasma concentration versus time curve for D-0316	Day 1 through 6, Cycle Day 1-Day 15
Secondary	Pharmacokinetic: maximum plasma drug concentration (Cmax)	Cmax: maximum plasma drug concentration of D-0316	Day 1 through 6, Cycle Day 1-Day 15
Secondary	Pharmacokinetic: Time to reach the Cmax (Tmax)	tmax: Time to reach the Cmax of D-0316	Day 1 through 6, Cycle Day 1-Day 15
Secondary	Pharmacokinetic: Apparent terminal half-life (t1/2)	t1/2: apparent terminal half-life of D-0316	Day 1 through 6, Cycle Day 1-Day 15
Secondary	Antitumor activity	Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)	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