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

NCT03450330 | Completed Phase 1

• 1 other identifier: DZ2017J0001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Nonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• safety and tolerability of AZD4205

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

  21 days after the first dose

Secondary Outcomes (3)

• Objective Response Rate (ORR)

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

• Peak Plasma Concentration (Cmax) of AZD4205

  1,8,15 days after first dose

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

  1,8,15 days after first dose

Study Arms (1)

daily dose of AZD4205

EXPERIMENTAL

daily dose of AZD4205

Drug: AZD4205

Interventions

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.

daily dose of AZD4205

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (4)

St George Hospital

Sydney, New South Wales, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

Northern Cancer Institute St Leonards

Sydney, 2066, Australia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pamela Yang, MD, PhD

  Dizal (Jiangsu) Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: dose escalation

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: March 1, 2018
• Study Start: April 16, 2018
• Primary Completion: September 3, 2019
• Study Completion: January 10, 2020
• Last Updated: August 24, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)