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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01802632
Registration number
NCT01802632
Ethics application status
Date submitted
25/02/2013
Date registered
1/03/2013
Date last updated
18/01/2024
Titles & IDs
Public title
AZD9291 First Time In Patients Ascending Dose Study
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Scientific title
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AZD9291 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
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Secondary ID [1]
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2012-004628-39
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Secondary ID [2]
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D5160C00001
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Universal Trial Number (UTN)
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Trial acronym
AURA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Non Small Cell Lung Cancer
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Advanced (Inoperable) Non Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD9291
Experimental: Daily dose of AZD9291 - Daily oral dose of AZD9291
Treatment: Drugs: AZD9291
Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) for Dose Expansion Population
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Assessment method [1]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or 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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Timepoint [1]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
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Primary outcome [2]
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Best Objective Response (BOR) for Dose Escalation Population
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Assessment method [2]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or 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; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
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Timepoint [2]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
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Primary outcome [3]
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Objective Response Rate (ORR) for Extension Population
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Assessment method [3]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or 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 independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.
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Timepoint [3]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
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Secondary outcome [1]
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Duration of Response (DoR) for Dose Expansion Population
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Assessment method [1]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or 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. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).
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Timepoint [1]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
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Secondary outcome [2]
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Progression-Free Survival (PFS) for Dose Expansion Population
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Assessment method [2]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.
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Timepoint [2]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)
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Secondary outcome [3]
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Best Objective Response (BOR) for 80mg AZD9291 Extension Population
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Assessment method [3]
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Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or 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; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.
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Timepoint [3]
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RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)
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Eligibility
Key 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).
- 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. All
patients must have documented radiological progression on the last treatment
administered prior to enrolling in the study.
- Patients (with the exception of 1st line expansion cohort) must fulfil one of the
following:
- Confirmation that the tumour harbours an EGFR mutation known to be associated
with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) OR
- Must have experienced clinical benefit from EGFR TKI, according to the Jackman
criteria (Jackman et al 2010) followed by systemic objective progression (RECIST
or WHO) while on continuous treatment with EGFR TKI.
- 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 (for 1st line patients biopsy will be
at time of diagnosis of advanced disease).
- For dose expansion and extension cohorts, patients must also have confirmation of
tumour T790M mutation status (confirmed positive or negative) from a biopsy sample
taken after disease progression on the most recent treatment regimen (irrespective of
whether this is EGFR TKI or chemotherapy).
Prior to entry a result from the central analysis of the patient's T790M mutation status
must be obtained.
- World Health Organisation (WHO) performance status 0-1 with no deterioration over the
previous 2 weeks and a minimum life expectancy of 12 weeks.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/12/2023
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Sample size
Target
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Accrual to date
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Final
603
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Heidelberg
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Recruitment hospital [2]
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Research Site - Kogarah
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Recruitment hospital [3]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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United States of America
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State/province [2]
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Georgia
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United States of America
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State/province [3]
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Massachusetts
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United States of America
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State/province [4]
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North Carolina
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Country [5]
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United States of America
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Tennessee
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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France
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State/province [7]
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Pierre Benite CEDEX
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Country [8]
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France
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State/province [8]
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Saint Herblain Cedex
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Country [9]
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France
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State/province [9]
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Villejuif
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Country [10]
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Germany
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State/province [10]
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Essen
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Germany
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State/province [11]
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Köln
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Germany
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State/province [12]
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Würzburg
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Italy
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Genova
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Italy
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State/province [14]
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Orbassano
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Country [15]
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Italy
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State/province [15]
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Roma
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Country [16]
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Japan
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State/province [16]
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Chiba-shi
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Country [17]
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Japan
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State/province [17]
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Fukuoka-shi
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Japan
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Fukuoka
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Japan
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State/province [19]
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Habikino-shi
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Country [20]
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Japan
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State/province [20]
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Hirakata-shi
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Country [21]
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Japan
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State/province [21]
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Hiroshima-shi
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Country [22]
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Japan
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State/province [22]
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Kanazawa
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Japan
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Kashiwa
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Japan
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Kobe-shi
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Japan
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Matsuyama-shi
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Japan
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Okayama-shi
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Japan
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Shinjuku-ku
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Japan
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Sunto-gun
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Japan
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Takatsuki-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Seoul
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Spain
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Madrid
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Spain
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Sevilla
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Manchester
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United Kingdom
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01802632
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Yuri Rukazenkov
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Address
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AstraZeneca
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Phone
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01802632
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