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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daily dose of AZD4205 | Experimental | daily dose of AZD4205 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4205 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of AZD4205 | Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v4.0 | 21 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Yang, MD, PhD | Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Hospital | Sydney | New South Wales | Australia | |||
| Austin Hospital |
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dose escalation
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| 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 | 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 | 1,8,15 days after first dose |
| Heidelberg |
| Victoria |
| 3084 |
| Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia |
| Northern Cancer Institute St Leonards | Sydney | 2066 | Australia |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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