Clinical trial NCT03450330: Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nonsmall Cell Lung Cancer
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: dose escalation
Primary purpose: TREATMENT

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 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.

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 with EGFR mutant advanced stage non-small cell lung cancer (NSCLC). This study includes dose escalation part and dose expansion part.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Any unsolved toxicity \> CTCAE grade 1 from previous anti-cancer therapy (except alopecia)
2. Active viral or bacterial infections;
3. Active or latent tuberculosis;
4. History of interstitial lung disease (ILD)
5. History of heart failure or QT interval prolongation
6. Immunodeficiency diseases;
7. Active CNS metastases
8. 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

Primary outcomes:
measure: safety and tolerability of AZD4205
timeFrame: 21 days after the first dose
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year
measure: Peak Plasma Concentration (Cmax) of AZD4205
timeFrame: 1,8,15 days after first dose
measure: Area under the plasma concentration versus time curve (AUC) of AZD4205
timeFrame: 1,8,15 days after first dose
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Sydney
country: Australia
facility: Northern Cancer Institute St Leonards
Study officials:
affiliation: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
name: Pamela Yang, MD, PhD
role: STUDY_DIRECTOR
References: