Clinical Trial VICCTHNP1353
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)
- Protocol No. VICCTHNP1353
- Open Date: 10/30/2013
- Staging: Phase I
- Age Group: Adults
- Scope: National
- Objective: To investigate the safety and tolerability of AZD9291 when given orally to patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have progressed following prior therapy with an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) agent.
- Disease Sites: Lung
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: AZD9291
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01802632
- Secondary Protocol No: D5160C00001
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
• Aged at least 18 years. Patients from Japan aged at least 20 years.
• Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
• Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib (with the exception of 1st line expansion cohort). In addition other lines of therapy may have been given.
• Previous treatment with a single-agent EGFR TKI (e.g. gefitinib or erlotinib).
• Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.
• Male patients should be willing to use barrier contraception.
• For 1st Line expansion cohort ONLY, confirmation that the tumour is EGFRm+ve and have had no prior therapy for their advanced disease.
• Treatment with an EGFR TKI (erlotinib or gefitinib) within 8 days (approximately 5x half-life) of the first dose of study treatment.
• Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
• AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this study).
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection.
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.