Trial | NCT03450330  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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.
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.
Study Started
Apr 16
2018
Primary Completion
Sep 03
2019
Study Completion
Jan 10
2020
Last Update
Aug 24
2020

Drug AZD4205

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.

daily dose of AZD4205 Experimental

daily dose of AZD4205

Criteria 

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
No Results Posted