A Phase I, Open-Label, Multicentre Dose-Escalation Study to Investigate the Safety and Pharmacokinetics of AZD5312 in Patients with Advanced Solid Tumours where the Androgen Receptor Pathway is a Potential Factor
Advanced Solid Tumours with Androgen Receptor Pathway as a Potential Factor
18 Years - 130 Years
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2018 by AstraZeneca
No locations available
AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be administered 4 times within the first 11 days, (on Days [1, 4, 8 and 11]± 2), with no dosing on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete Cycle 1. During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2).
AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers.
Other Name: ISIS 560131