Advanced Solid Tumours With Androgen Receptor Pathway as a Potential Factor Clinical Trial
Official title:
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
This is a first time in man (FTIM), Phase I study to determine the Maximum Tolerated Dose,
Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a
multicentre study with sites in the United States and United Kingdom. Approximately 90
patients are expected to be enrolled in this study.
The study involves two parts, Part A, Dose Escalation and Part B, Dose Expansion.
This is a first time in man (FTIM), Phase I study to determine the Maxiimum Tolerated Dose,
Recommended Phase 2 Dose, safety, tolerability and Pharmacokinetics of AZD5312. This is a
multicentre study with sites in the United States and United Kingdom. Approximately 90
patients are expected to be enrolled in this study.The study involves two parts, Part A,
Dose Escalation and Part B, Dose Expansion.
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). The AZD5312 dose will not change unless dose reductions are required due to
treatment-related toxicity. Patients will continue to receive AZD5312 until disease
progression, intolerable toxicity, or discontinuation criteria have been met. Toxicity,
Pharmacokinetics and biomarker data will be assessed throughout the study. Alternative
infusion durations and/or treatment schedules may be explored if preliminary data suggest
these would be more appropriate.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment