Clinical trial NCT03452150: D-0316 First Time in Patients Ascending Dose Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Non Small Cell Lung Cancer
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Dose Limiting Toxicities (DLTs)
timeFrame: Day 1 - Day 28
measure: Adverse events
timeFrame: Day 1 - Day 28
measure: Laboratory results
timeFrame: Day 1 - Day 28
measure: Vital signs
timeFrame: Day 1 - Day 28
measure: Electrocardiogram
timeFrame: Day 1 - Day 28
Secondary outcomes:
measure: Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
timeFrame: Day 1 through 6, Cycle Day 1-Day 15
measure: Pharmacokinetic: maximum plasma drug concentration (Cmax)
timeFrame: Day 1 through 6, Cycle Day 1-Day 15
measure: Pharmacokinetic: Time to reach the Cmax (Tmax)
timeFrame: Day 1 through 6, Cycle Day 1-Day 15
measure: Pharmacokinetic: Apparent terminal half-life (t1/2)
timeFrame: Day 1 through 6, Cycle Day 1-Day 15
measure: Antitumor activity
timeFrame: 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
Other outcomes:
Locations:
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
References:
citation: Jian H, Wang K, Cheng Y, Ding L, Wang Y, Shi Z, Zhang L, Wang Y, Lu S. Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. Oncologist. 2022 Mar 11;27(3):163-e213. doi: 10.1093/oncolo/oyab007.