Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

Study identifier:D3610C00001

ClinicalTrials.gov identifier:NCT01226316

EudraCT identifier:2010-022167-35

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies

Medical condition

Advanced solid malignancy, pharmacokinetics

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD5363

Sex

All

Actual Enrollment

285

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Dec 2010
Primary Completion Date: 26 Apr 2019
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria