Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

Launched by ASTRAZENECA · Jul 8, 2013

Keywords

ClinConnect Summary

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 (ie, how quickly the body absorbs and removes the drug), the comparison of a capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: -
• • 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 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 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