Tolerability,Pharmacokinetics&Preliminary Antitumour Activity of Ascending Doses of AZD9291 in Patients With Advanced Non Small Cell LungCancer Who Have Progressed Following Prior Therapy With an Epidermal Growth FactorReceptorTyrosineKinaseInhibatoragent
N/A
N/A
Both
Advanced Non Small Cell Lung Cancer, Advanced (Inoperable) Non Small Cell Lung Cancer
Trial Information
Tolerability,Pharmacokinetics&Preliminary Antitumour Activity of Ascending Doses of AZD9291 in Patients With Advanced Non Small Cell LungCancer Who Have Progressed Following Prior Therapy With an Epidermal Growth FactorReceptorTyrosineKinaseInhibatoragent
Tolerability,Pharmacokinetics&Preliminary Antitumour Activity of Ascending Doses of AZD9291
in Patients with Advanced Non Small Cell LungCancer who have Progressed Following Prior
Therapy with an Epidermal Growth FactorReceptorTyrosineKinaseInhibatoragent
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of AZD9291, as assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram and opthalmic examinations
Outcome Description:
AEs collected from consent until 28 days after the last dose.Physical exam conducted:screening,first dosing day,first day of multiple dosing(dose escalation),Day 1 of every 3-week cycle and treatment discontinuation.ECG profile,vital signs assessed day after first dose,steady state(Day 8,Day 9, cycle 1)and if occurrence of any cardiac adverse event.Lab variables assessed at screening,first dosing day,first day of multiple dosing,weekly for first cycle,Day 1 of every subsequent 3-week cycle and treatment discontinuation.Eye exam at baseline and upon occurrence of any visual AE.
Outcome Time Frame:
Adverse events will be collected from baseline until 28 days after the last dose, expected average 6 months
Safety Issue:
Yes
Principal Investigator
Serban Ghiorghiu, MSD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
D5160C00001
NCT ID:
NCT01802632
Start Date:
March 2013
Completion Date:
July 2015
Related Keywords:
- Advanced Non Small Cell Lung Cancer
- Advanced (Inoperable) Non Small Cell Lung Cancer
- Oncology,
- Non Small Cell Lung Cancer,
- Metastatic,
- EGFR sensitivity mutation,
- T790M resistance mutation
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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