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



Status:Active, not recruiting
Conditions:Breast Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies, Endometrial Cancer
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - 127
Updated:1/5/2019
Start Date:December 1, 2010
End Date:November 19, 2019

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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

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.

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.
We found this trial at
11
sites
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Oklahoma City, OK
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Aurora, CO
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Boston, MA
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Charleston, South Carolina 29412
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Charleston, SC
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Edmonton,
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Houston, TX
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Los Angeles, CA
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Nashville, TN
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New York, NY
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Portland, OR
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Stanford, CA
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