Trial Search Results

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

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-tumor activity of AZD5363 in patients with advanced / metastatic breast and gynecological cancers.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:


Stanford Investigator(s):


  • Drug: AZD5363
  • Drug: AZD5363
  • Drug: AZD5363
  • Drug: AZD5363


Phase 1


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.

Ages Eligible for Study

18 Years - 130 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting