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

Dizal Pharmaceuticals10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nonsmall Cell Lung Cancer

Interventions

AZD4205DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

St George Hospital

Sydney, New South Wales, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Northern Cancer Institute St Leonards

Sydney, Australia

Outcomes

Primary Outcomes

safety and tolerability of AZD4205

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

Time frame: 21 days after the first dose

Secondary Outcomes

Objective Response Rate (ORR)

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.

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

Peak Plasma Concentration (Cmax) of AZD4205

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

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

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

Data from ClinicalTrials.gov

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