Brief Title
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
Official Title
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
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events
Secondary Outcome
To characterise AZD5363 PK following single & multiple dosing by assessment of maximum plasma concentration,time to Cmax, terminal rate constant, terminal half life,area under the plasma concentration-time curve,plasma clearance & volume of distribution.
Condition
Advanced Solid Malignancy
Intervention
AZD5363
Study Arms / Comparison Groups
Part A and B Schedule 1, Continuous dosing
Description: Part A: Ascending doses of AZD5363 administered orally, every day to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
285
Start Date
December 1, 2010
Completion Date
December 31, 2021
Primary Completion Date
April 26, 2019
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.
Gender
All
Ages
18 Years - 130 Years
Accepts Healthy Volunteers
No
Contacts
Gaia Schiavon, MSD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01226316
Organization ID
D3610C00001
Secondary IDs
EudraCT number: 2010-022167-35
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
Gaia Schiavon, MSD, Study Director, AstraZeneca
Verification Date
December 2020