AZD9291 First Time In Patients Ascending Dose Study
Diagnosis: Lung Cancer
NCT ID: NCT01802632
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-344
This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. 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 measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Pasi Janne, MD, PhD,
Dana-Farber Cancer Institute
Lecia Sequist, MD,
Massachusetts General Hospital
Dana-Farber Cancer Institute:
Kelly Masone, 617-632-3383,
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
- 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
- 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 a
previous treatment regimen or clinical study within 14 days of the first dose of
- AZD9291 in the present study (ie, dosing with AZD9291 previously initiated in this
- 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.