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Official Title

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d5160c00002-study-synopsis_Redacted.pdf

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Phase II AZD9291 open label study in NSCLC after previous EGFR TKI therapy in EGFR and T790M mutation positive tumours

This is a phase II, open label, single arm study assessing the safety and efficacy of AZD9291 (80 mg, orally, once daily) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen.  The primary objective of the study is to assess the efficacy of AZD9291 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.

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EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

D5160C00002_12_1_01csp_andamendments_Redacted1

Research Site

Phase II, Open Label, Single-arm Study to Assess Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic NSCLC whose Disease has Progressed with Previous EGFR TKI and whose Tumours are EGFR and T790M Mutation Positive

To assess the efficacy of AZD9291 by assessment of Objective Response Rate (ORR) by Independent Central Review.

Age Continuous

Age, Customized

Race/Ethnicity, Customized

Sex: Female, Male

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 (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.

Objective Response Rate (ORR)

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).

All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.

Duration of Response (DoR)

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. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.

Disease Control Rate (DCR)

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 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.

All patients who received at least 1 dose of study treatment.

Progression-Free Survival (PFS)

Overall Study

472 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all the inclusion and none of the exclusion criteria. 262 patients were enrolled but failed inclusion/exclusion criteria and so were not eligible to be assigned treatment. The remaining 210 patients received treatment.

Senior Medical Director, Tagrisso

To assess the efficacy of AZD9291 regarding Progression Free Survival (PFS).

To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550)

To assess the impact of AZD9291 on patients’ disease-related symptoms and health related quality of life (HRQoL).

To investigate the effects of AZD9291 on QTc interval after oral dosing to NSCLC patients.

To assess the efficacy of AZD9291 regarding overall survival.

To assess the efficacy of AZD9291 regarding Duration of response (DoR)

To assess the efficacy of AZD9291 regarding Disease Control Rate (DCR).

To assess the efficacy of AZD9291 regarding tumour shrinkage.

To assess the impact of AZD9291 on patients' disease-related symptoms and health related quality of life (HRQoL).

Phase II AZD9291 open label study in NSCLC after previous EGFR TKI therapy in EGFR and T790M mutation positive tumours - AURA2

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Documents available

D5160C00002_12_1_01csp_andamendments_Redacted1

CSR synopsis

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