A Phase 1, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 uUnder Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies.
- Conditions
- Advanced Solid Malignancy, Advanced or Metastatic Breast Cancer, Ovarian Cancer, Cervical Cancer, Endometrial Cancer
- Registration Number
- JPRN-jRCT2080222792
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 25
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)
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>other<br>-
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacodynamics<br>-