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Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules | Clinical Trials | Clareo Health

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

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

NCT01226316•AstraZeneca

View on ClinicalTrials.gov

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.

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 Patients with Advanced Solid Malignancies.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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.

Locations (34)

Research Site

Los Angeles, California, United States

Research Site

Stanford, California, United States

Research Site

West Hollywood, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Boston, Massachusetts, United States

Research Site

New York, New York, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Portland, Oregon, United States

Research Site

Charleston, South Carolina, United States

Research Site

Nashville, Tennessee, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

April 26, 2019

Completion Date

December 3, 2024

Last Updated

June 29, 2025

Enrollment

285

ACTUAL participants

Conditions

Advanced Solid MalignancySafety and TolerabilityPharmacokineticsPharmacodynamicsTumour ResponseAdvanced or Metastatic Breast CancerOvarian CancerCervical CancerEndometrial CancerPIK3CAAKT1PTENER PositiveHER2 Positive

Interventions

AZD5363

DRUG

AZD5363

DRUG

AZD5363

DRUG

AZD5363

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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