Advanced Solid Malignancy, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer
Conditions
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 18 Years and older ( 20 Years and older in Japan)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety other - | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacodynamics - | — |
Countries
Canada, Denmark, France, Italy, Netherlands, Singapore, Spain, UK, US
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed