Nonsmall Cell Lung CancerPhase 1/2JACKPOT1NCT03450330
Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing AZD4205 in people with Nonsmall Cell Lung Cancer, run by Dizal Pharmaceuticals at 4 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- What is being tested?
- AZD4205
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesAustralia
- Study dates
- 16 Apr 2018to 10 Jan 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Austin Hospital
Heidelberg, Victoria, 3084
Peter MacCallum Cancer Centre
Melbourne, Victoria
St George Hospital
Sydney, New South Wales
Northern Cancer Institute St Leonards
Sydney, 2066
About this study
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)
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.
Read the 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.
- Conditions
- Nonsmall Cell Lung Cancer
- Being tested
- AZD4205
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| daily dose of AZD4205 | Experimental | daily dose of AZD4205 Receives: Drug: AZD4205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of AZD4205
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0
Measured: 21 days after the first dose
Secondary outcomes (3)
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.
Measured: RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year
Peak Plasma Concentration (Cmax) of AZD4205
Peak Plasma Concentration (Cmax) of AZD4205
Measured: 1,8,15 days after first dose
Area under the plasma concentration versus time curve (AUC) of AZD4205
Area under the plasma concentration versus time curve (AUC) of AZD4205
Measured: 1,8,15 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start16 Apr 2018
- Primary completion3 Sep 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- dose escalation
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Yang, MD, PhD, Study director, Dizal (Jiangsu) Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450330
- Sponsor's protocol ID
- DZ2017J0001
- Acronym
- JACKPOT1
- Status last verified
- Nov 2019
- First submitted
- 25 Jan 2018
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03450330
- Acronym / sponsor ID
- JACKPOT1 / DZ2017J0001
- Conditions
- Nonsmall Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dose escalation
| Arm | Type | Receives |
|---|---|---|
| daily dose of AZD4205 | Experimental | Drug: AZD4205daily dose of AZD4205 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD4205Daily 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. | Drug | daily dose of AZD4205 |
Primary outcome
safety and tolerability of AZD4205
Time frame: 21 days after the first dose
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0
3 secondary outcomes
Objective Response Rate (ORR)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Yang, MD, PhD study director
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD4205 in people with Nonsmall Cell Lung Cancer, run by Dizal Pharmaceuticals at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability of AZD4205 (time frame: 21 days after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.