Description:
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.
Title
- Brief Title: Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer
- 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 IDs
- ORG STUDY ID:
DZ2017J0001
- NCT ID:
NCT03450330
Conditions
- Nonsmall Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
AZD4205 | | daily dose of AZD4205 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
daily dose of AZD4205 | Experimental | daily dose of AZD4205 | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | safety and tolerability of AZD4205 |
Time Frame: | 21 days after the first dose |
Safety Issue: | |
Description: | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0 |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | RECIST tumour assessments every 6 weeks from enrollment until study completion, an average of 1 year |
Safety Issue: | |
Description: | 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. |
Measure: | Peak Plasma Concentration (Cmax) of AZD4205 |
Time Frame: | 1,8,15 days after first dose |
Safety Issue: | |
Description: | Peak Plasma Concentration (Cmax) of AZD4205 |
Measure: | Area under the plasma concentration versus time curve (AUC) of AZD4205 |
Time Frame: | 1,8,15 days after first dose |
Safety Issue: | |
Description: | Area under the plasma concentration versus time curve (AUC) of AZD4205 |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Dizal Pharmaceuticals |
Last Updated
August 24, 2020