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

Status: Closed to Accrual


This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

Eligibility Criteria

Inclusion Criteria

  • Aged at least 18 years.
  • Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
  • ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F).
  • The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.
  • Estimated life expectancy of more than 12 weeks.

Exclusion Criteria

  • Clinically significant abnormalities of glucose metabolism.
  • Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
  • Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  • Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
  • A bad reaction to AZD5363 or any drugs similar to it in structure or class.

Locations & Contacts


Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Name Not Available


New Haven
Yale University
Status: Active
Contact: Joseph Paul Eder
Phone: 203-785-5702

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: David Michael Hyman
Phone: 212-639-7202


University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Adam Matthew Brufsky
Phone: 412-647-2811

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type


Lead Organization

Lead Organization
AstraZeneca Pharmaceuticals LP

Trial IDs

Primary ID D3610C00001
Secondary IDs NCI-2014-01803, EudraCT number: 2010-022167-35 ID NCT01226316