Clinical trial NCT01895946: Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Official title: A Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancy,
Safety and Tolerability,
Pharmacokinetics, Pharmacodynamics,
Tumour Response,
Keywords: Advanced solid malignancy, AZD5363,
food effect,
formulation comparison
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

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

Primary outcomes:
measure: Ratio of Css,Max for Day 4 to Day 11
timeFrame: Day 4 and Day 11
measure: Ratio of AUCss for Day 4 to Day 11
timeFrame: Day 4 and Day 11
Secondary outcomes:
measure: Efficacy: Best Objective Response (BOR)
timeFrame: Assessed every 6 weeks, up to 36 weeks
measure: Efficacy: Disease Control at Week 12
timeFrame: Week 12
measure: Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12
timeFrame: Week 12
measure: Efficacy: Target Lesion Size, Best Percentage Change From Baseline
timeFrame: Assessed every 6 weeks up to 36 weeks
measure: Efficacy: Progression-free Survival (PFS)
timeFrame: Assessed every 6 weeks up to 36 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Surrey
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Justin Lindemann, MSD
role: STUDY_DIRECTOR
affiliation: Institute of Cancer Research, United Kingdom
name: Udai Banerji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: