Breast Cancer Clinical Trial
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
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 study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.
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 Patients with Advanced Solid Malignancies.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 34 Locations for this study
Los Angeles California, 90089, United States
Stanford California, 94304, United States
West Hollywood California, 90048, United States
Aurora Colorado, 80045, United States
Boston Massachusetts, 02215, United States
New York New York, 10022, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29425, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37204, United States
Houston Texas, 77030, United States
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
KÃ¸benhavn Ã˜ , 2100, Denmark
Paris Cedex 5 , 75248, France
Pierre Benite CEDEX , 69310, France
Villejuif , 94805, France
Milan , 20141, Italy
Napoli , 80131, Italy
Prato , 59100, Italy
Chuo-ku , 104-0, Japan
Kashiwa , 277-8, Japan
Koto-ku , 135-8, Japan
Sapporo-shi , 060-8, Japan
Amsterdam , 1066 , Netherlands
Singapore , 11922, Singapore
Madrid , 08035, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Manchester , M20 4, United Kingdom
Sutton , SM2 5, United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.