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.

AstraZeneca KK0 个研究点目标入组 25 人开始时间: 2015年3月11日最近更新: 2023年10月17日

适应症

试验速览

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•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

发起方