Clinical Trials /

Assessing an Oral Janus Kinase Inhibitor, AZD4205, in Combination With Osimertinib in Patients Who Have Advanced Non-small Cell Lung Cancer

NCT03450330

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
AZD4205daily 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

NameTypeDescriptionInterventions
daily dose of AZD4205Experimentaldaily dose of AZD4205
  • 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:Recruiting
Lead Sponsor:Dizal (Jiangsu) Pharmaceutical Co., Ltd.

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