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

Nonsmall Cell Lung Cancer Clinical Trial

— JACKPOT1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450330
• Other study ID #: DZ2017J0001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 16, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: November 2019
• Source: Dizal Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 10, 2020
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Northern Cancer Institute St Leonards	Sydney
Australia	St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Dizal Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability of AZD4205	Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0	21 days after the first dose
Secondary	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.	RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year
Secondary	Peak Plasma Concentration (Cmax) of AZD4205	Peak Plasma Concentration (Cmax) of AZD4205	1,8,15 days after first dose
Secondary	Area under the plasma concentration versus time curve (AUC) of AZD4205	Area under the plasma concentration versus time curve (AUC) of AZD4205	1,8,15 days after first dose