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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03450330




Registration number
NCT03450330
Ethics application status
Date submitted
25/01/2018
Date registered
27/02/2018
Date last updated
11/10/2018

Titles & IDs
Public title
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
Scientific 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)
Secondary ID [1] 0 0
DZ2017J0001
Universal Trial Number (UTN)
Trial acronym
JACKPOT1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonsmall Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD4205

Experimental: daily dose of AZD4205 - daily dose of AZD4205


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
safety and tolerability of AZD4205 - Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0
Timepoint [1] 0 0
21 days after the first dose
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year
Secondary outcome [2] 0 0
Peak Plasma Concentration (Cmax) of AZD4205 - Peak Plasma Concentration (Cmax) of AZD4205
Timepoint [2] 0 0
1,8,15 days after first dose
Secondary outcome [3] 0 0
Area under the plasma concentration versus time curve (AUC) of AZD4205 - Area under the plasma concentration versus time curve (AUC) of AZD4205
Timepoint [3] 0 0
1,8,15 days after first dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Northern Cancer Institute St Leonards - Sydney
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
2066 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03450330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pamela Yang, MD, PhD
Address 0 0
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jason Li, MD
Address 0 0
Country 0 0
Phone 0 0
00862161097868
Fax 0 0
Email 0 0
jason.li@dizalpharma.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable