Status:
COMPLETED
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Malignancy
Safety and Tolerability
Eligibility:
All Genders
18-130 years
Phase:
PHASE1
Brief Summary
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 st...
Detailed Description
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 Pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2024
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT01226316
Start Date
December 1 2010
End Date
December 3 2024
Last Update
June 29 2025
Active Locations (34)
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1
Research Site
Los Angeles, California, United States, 90089
2
Research Site
Stanford, California, United States, 94304
3
Research Site
West Hollywood, California, United States, 90048
4
Research Site
Aurora, Colorado, United States, 80045