Status:
COMPLETED
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Dizal Pharmaceuticals
Conditions:
Nonsmall Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 wha...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03450330
Start Date
April 16 2018
End Date
January 10 2020
Last Update
August 24 2020
Active Locations (4)
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1
St George Hospital
Sydney, New South Wales, Australia
2
Austin Hospital
Heidelberg, Victoria, Australia, 3084
3
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
4
Northern Cancer Institute St Leonards
Sydney, Australia, 2066