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

Completed · Phase 1

Conditions studied: Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, Tumour Response, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, PIK3CA, AKT1, PTEN, ER Positive, HER2 Positive

In brief

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.

Key facts

Study ID

NCT01226316

Run by

AstraZeneca

People needed

285

Starts

2010-12-01

Expected to finish

2024-12-03

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Stanford, California, United States
• Research Site — West Hollywood, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — New York, New York, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Portland, Oregon, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site — Edmonton, Alberta, Canada
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — København Ø, Denmark
• Research Site — Paris, France
• Research Site — Pierre-Bénite, France
• Research Site — Villejuif, France
• Research Site — Milan, Italy
• Research Site — Naples, Italy
• Research Site — Prato, Italy
• Research Site — Chūōku, Japan
• Research Site — Kashiwa, Japan

Full record on ClinicalTrials.gov

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