Advanced Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGD-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
Sponsors
InventisBio Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities (DLTs) | Day 1 - Day 28 | Incidence of DLTs |
| Adverse events | Day 1 - Day 28 | Incidence of AEs |
| Laboratory results | Day 1 - Day 28 | Incidence of laboratory abnormalities |
| Vital signs | Day 1 - Day 28 | Incidence of vital sign abnormalities |
| Electrocardiogram | Day 1 - Day 28 | Incidence of ECG abnormalities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic: area under the plasma concentration versus time curve (AUC) | Day 1 through 6, Cycle Day 1-Day 15 | AUC: area under the plasma concentration versus time curve for D-0316 |
| Pharmacokinetic: maximum plasma drug concentration (Cmax) | Day 1 through 6, Cycle Day 1-Day 15 | Cmax: maximum plasma drug concentration of D-0316 |
| Pharmacokinetic: Time to reach the Cmax (Tmax) | Day 1 through 6, Cycle Day 1-Day 15 | tmax: Time to reach the Cmax of D-0316 |
| Pharmacokinetic: Apparent terminal half-life (t1/2) | Day 1 through 6, Cycle Day 1-Day 15 | t1/2: apparent terminal half-life of D-0316 |
| Antitumor activity | 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 | Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1) |
Countries
China
Outcome results
None listed