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Completed

NCT Number: NCT03450330

Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

This study will treat patients with advanced NSCLC who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy and in combination with Osimertinib.

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Key information

Conditions

Nonsmall Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St George Hospital, Sydney, New South Wales, Australia

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About this study

A phase I/II, open-label, multicentre study to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of AZD4205 as monotherapy or in combination with Osimertinib in patients with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obtained written informed consent
  • Patients must have histological or cytological confirmation of activating EGFR mutation positive NSCLC and have failed prior EGFR TKIs treatment.
  • Patients must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate bone marrow reserve and organ system functions

Exclusion criteria

  • Any unsolved toxicity > CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
  • Active viral or bacterial infections;
  • Active or latent tuberculosis;
  • History of interstitial lung disease (ILD)
  • History of heart failure or QT interval prolongation
  • Immunodeficiency diseases;
  • Active CNS metastases
  • Treatment with an EGFR TKI (e.g., erlotinib or gefitinib) within 8 days or approximately 5 x half-life, whichever is longer, of the first dose of study treatment

Treatment and study plan

AZD4205

Drug

Daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. Starting dose of AZD4205 at 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.

Primary outcomes

  1. safety and tolerability of AZD4205

    Time frame: 21 days after the first dose

    Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year

    Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

  2. Peak Plasma Concentration (Cmax) of AZD4205

    Time frame: 1,8,15 days after first dose

    Peak Plasma Concentration (Cmax) of AZD4205

  3. Area under the plasma concentration versus time curve (AUC) of AZD4205

    Time frame: 1,8,15 days after first dose

    Area under the plasma concentration versus time curve (AUC) of AZD4205

Sponsors and collaborators

Lead sponsor

Dizal Pharmaceuticals

Industry

Registry information

Official study title

A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD4205 as Monotherapy or in Combination With Osimertinib in Patients With EGFR Mutant Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Acronym: JACKPOT1

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 1, 2018
Registry last updated
Aug 24, 2020

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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