At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
AZD5363 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AZD5363 for Advanced Solid Malignancy, and 3 related conditions. Completed, enrolled 33 participants across 3 sites in 2 countries.
Detailed Summary
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Malignancy,, Safety and Tolerability,, Pharmacokinetics, Pharmacodynamics,, Tumour Response,
CountriesNetherlands, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartDec 2013
Primary CompletionFeb 2015
Study CompletionJul 2015
TodayJul 2026
First PostedJul 11, 2013
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.0 years ago
Interventions
AZD5363drug
Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.
AZD5363drug
Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.