Breast Cancer Clinical Trial

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

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 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.

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Full 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 Patients with Advanced Solid Malignancies.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

285

Study ID:

NCT01226316

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 34 Locations for this study

See Locations Near You

Research Site
Los Angeles California, 90089, United States
Research Site
Stanford California, 94304, United States
Research Site
West Hollywood California, 90048, United States
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Aurora Colorado, 80045, United States
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Boston Massachusetts, 02215, United States
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New York New York, 10022, United States
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Oklahoma City Oklahoma, 73104, United States
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Portland Oregon, 97239, United States
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Charleston South Carolina, 29425, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37204, United States
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Houston Texas, 77030, United States
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Edmonton Alberta, T6G 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H4A 3, Canada
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København Ø , 2100, Denmark
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Paris Cedex 5 , 75248, France
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Pierre Benite CEDEX , 69310, France
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Villejuif , 94805, France
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Prato , 59100, Italy
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Chuo-ku , 104-0, Japan
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Kashiwa , 277-8, Japan
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Koto-ku , 135-8, Japan
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Sapporo-shi , 060-8, Japan
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Amsterdam , 1066 , Netherlands
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Singapore , 11922, Singapore
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Madrid , 08035, Spain
Research Site
Madrid , 28041, Spain
Research Site
Valencia , 46010, Spain
Research Site
Manchester , M20 4, United Kingdom
Research Site
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

285

Study ID:

NCT01226316

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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