Nonsmall Cell Lung Cancer
Conditions
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.
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.
Interventions
DRUGAZD4205
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.
Sponsors
Dizal Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
dose escalation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety and tolerability of AZD4205 | 21 days after the first dose | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year | 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. |
| Peak Plasma Concentration (Cmax) of AZD4205 | 1,8,15 days after first dose | Peak Plasma Concentration (Cmax) of AZD4205 |
| Area under the plasma concentration versus time curve (AUC) of AZD4205 | 1,8,15 days after first dose | Area under the plasma concentration versus time curve (AUC) of AZD4205 |
Countries
Australia
Outcome results
None listed