Status:
COMPLETED
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Malignancy,
Safety and Tolerability,
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Detailed Description
This study is designed to investigate the safety, tolerability and pharmacokinetics of a new drug, AZD5363, in patients with advanced cancer . This study will investigate how the body handles AZD5363 ...
Eligibility Criteria
Inclusion
- Aged at least 18 years
- The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist
- The presence of at least one lesion that can be accurately assessed at baseline by Computerised Tomography (CT), Magnetic Resonance Imaging (MRI) or plain X-ray and is suitable for repeated assessment
- Estimated life expectancy of more than 12 weeks
Exclusion
- 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 Human Immunodeficiency Virus (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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01895946
Start Date
December 1 2013
End Date
July 1 2015
Last Update
May 25 2016
Active Locations (3)
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1
Research Site
Amsterdam, Netherlands, 1066 CX
2
Research Site
Manchester, United Kingdom, M20 4BX
3
Research Site
Surrey, United Kingdom, SM2 5PT