A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in Patients With Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients With Known PTEN-deficient Advanced Solid Malignancies, With Expansion to Assess the Pharmacodynamic Activity of AZD8186 Within Prospectively-validated PTEN Deficient Tumours
A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability,
Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD8186 in
Patients with Advanced Castrate-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell
Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and patients with known
PTEN-deficient Advanced Solid Malignancies, with Expansion to Assess the Pharmacodynamic
Activity of AZD8186 within Prospectively-validated PTEN deficient Tumours
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Parts A and B: Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, pulse, blood pressure, weight and laboratory variables
Routine safety assessments, throughout the period that patients receive AZD8186 up to 30 days following discontinuation of last dose of study treatment.
Yes
Glen Clack
Study Director
AstraZeneca
United Kingdom: Medicines and Healthcare Products Regulatory Agency
D4620C00001
NCT01884285
June 2013
March 2015
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