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

Not Recruiting

Trial ID: NCT01226316


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.

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

Stanford Investigator(s)

Mark Pegram

Susy Yuan-Huey Hung Professor

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Mary Lake Polan Professor


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.


drug: AZD5363

drug: AZD5363

drug: AZD5363

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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