AZD9291 First Time In Patients Ascending Dose Study

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT01802632
• Date of registration: 25/02/2013
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: AZD9291 First Time In Patients Ascending Dose Study AURA
• 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
• Date of first enrolment: March 4, 2013
• Target sample size: 603
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01802632
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, France, Germany, Italy, Japan, Korea, Republic of, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Yuri Rukazenkov
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Advanced (Inoperable) Non Small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer

Intervention(s)

Drug: AZD9291

Primary Outcome(s)

Best Objective Response (BOR) for Dose Escalation Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)]

Objective Response Rate (ORR) for Extension Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)]

Objective Response Rate (ORR) for Dose Expansion Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)]

Secondary Outcome(s)

Duration of Response (DoR) for Dose Expansion Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)]

Progression-Free Survival (PFS) for Dose Expansion Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)]

Best Objective Response (BOR) for 80mg AZD9291 Extension Population [Time Frame: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)]

Secondary ID(s)

2012-004628-39

D5160C00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01802632