Back to resultsD-0316 First Time in Patients Ascending Dose Study
Primary Purpose
Advanced Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
D-0316
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer
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
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Daily oral dose of D-0316
Arm Description
Outcomes
Primary Outcome Measures
Dose Limiting Toxicities (DLTs)
Incidence of DLTs
Adverse events
Incidence of AEs
Laboratory results
Incidence of laboratory abnormalities
Vital signs
Incidence of vital sign abnormalities
Electrocardiogram
Incidence of ECG abnormalities
Secondary Outcome Measures
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0316
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0316
Pharmacokinetic: Time to reach the Cmax (Tmax)
tmax: Time to reach the Cmax of D-0316
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0316
Antitumor activity
Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03452150
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InventisBio Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily oral dose of D-0316
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
D-0316
Intervention 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
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLTs)
Description
Incidence of DLTs
Time Frame
Day 1 - Day 28
Title
Adverse events
Description
Incidence of AEs
Time Frame
Day 1 - Day 28
Title
Laboratory results
Description
Incidence of laboratory abnormalities
Time Frame
Day 1 - Day 28
Title
Vital signs
Description
Incidence of vital sign abnormalities
Time Frame
Day 1 - Day 28
Title
Electrocardiogram
Description
Incidence of ECG abnormalities
Time Frame
Day 1 - Day 28
Secondary Outcome Measure Information:
Title
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
Description
AUC: area under the plasma concentration versus time curve for D-0316
Time Frame
Day 1 through 6, Cycle Day 1-Day 15
Title
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Description
Cmax: maximum plasma drug concentration of D-0316
Time Frame
Day 1 through 6, Cycle Day 1-Day 15
Title
Pharmacokinetic: Time to reach the Cmax (Tmax)
Description
tmax: Time to reach the Cmax of D-0316
Time Frame
Day 1 through 6, Cycle Day 1-Day 15
Title
Pharmacokinetic: Apparent terminal half-life (t1/2)
Description
t1/2: apparent terminal half-life of D-0316
Time Frame
Day 1 through 6, Cycle Day 1-Day 15
Title
Antitumor activity
Description
Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35274722
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.
Results Reference
derived
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D-0316 First Time in Patients Ascending Dose Study
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