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

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.