NCT03452150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

February 13, 2018

Last Update Submit

April 23, 2023

Conditions

Advanced Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

  • Dose Limiting Toxicities (DLTs)

    Incidence of DLTs

    Day 1 - Day 28

  • Adverse events

    Incidence of AEs

    Day 1 - Day 28

  • Laboratory results

    Incidence of laboratory abnormalities

    Day 1 - Day 28

  • Vital signs

    Incidence of vital sign abnormalities

    Day 1 - Day 28

  • Electrocardiogram

    Incidence of ECG abnormalities

    Day 1 - Day 28

Secondary Outcomes (5)

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

    Day 1 through 6, Cycle Day 1-Day 15

  • Pharmacokinetic: maximum plasma drug concentration (Cmax)

    Day 1 through 6, Cycle Day 1-Day 15

  • Pharmacokinetic: Time to reach the Cmax (Tmax)

    Day 1 through 6, Cycle Day 1-Day 15

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

    Day 1 through 6, Cycle Day 1-Day 15

  • 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

Study Arms (1)

Daily oral dose of D-0316

EXPERIMENTAL
Drug: D-0316

Interventions

D-0316DRUG

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

Daily oral dose of D-0316

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Changchun, Jilin, 130012, China

Location

Research Site

Shanghai, Shanghai Municipality, 200030, China

Location

Research Site

Hangzhou, Zhejiang, 310052, China

Location

Related Publications (1)

  • 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.

    PMID: 35274722DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

March 2, 2018

Study Start

January 3, 2018

Primary Completion

August 28, 2020

Study Completion

December 31, 2020

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(3)