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Completed

NCT Number: NCT03452150

D-0316 First Time in Patients Ascending Dose Study

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.

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Key information

Conditions

Advanced Non Small Cell Lung Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Changchun, Jilin, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D-0316

Drug

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 outcomes

  1. Dose Limiting Toxicities (DLTs)

    Time frame: Day 1 - Day 28

    Incidence of DLTs

  2. Adverse events

    Time frame: Day 1 - Day 28

    Incidence of AEs

  3. Laboratory results

    Time frame: Day 1 - Day 28

    Incidence of laboratory abnormalities

  4. Vital signs

    Time frame: Day 1 - Day 28

    Incidence of vital sign abnormalities

  5. Electrocardiogram

    Time frame: Day 1 - Day 28

    Incidence of ECG abnormalities

Secondary outcomes

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

    Time frame: Day 1 through 6, Cycle Day 1-Day 15

    AUC: area under the plasma concentration versus time curve for D-0316

  2. Pharmacokinetic: maximum plasma drug concentration (Cmax)

    Time frame: Day 1 through 6, Cycle Day 1-Day 15

    Cmax: maximum plasma drug concentration of D-0316

  3. Pharmacokinetic: Time to reach the Cmax (Tmax)

    Time frame: Day 1 through 6, Cycle Day 1-Day 15

    tmax: Time to reach the Cmax of D-0316

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

    Time frame: Day 1 through 6, Cycle Day 1-Day 15

    t1/2: apparent terminal half-life of D-0316

  5. Antitumor activity

    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

    Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 2, 2018
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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