Phase 1
Completed N=30
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Advanced Solid Malignancy, · Safety and Tolerability, · Pharmacokinetics, Pharmacodynamics, · Tumour Response,
Source: ClinicalTrials.gov NCT01895946 ↗
Enrolled (actual)
30
Serious AEs
36.7%
Results posted
May 2016
Primary outcomePrimary: Ratio of Css,Max for Day 4 to Day 11 — 1.02; 0.67 Ratio
Summary
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Css,Max for Day 4 to Day 11 |
1.02; 0.67 | — |
| PRIMARY Ratio of AUCss for Day 4 to Day 11 |
0.90; 0.89 | — |
| SECONDARY Efficacy: Best Objective Response (BOR) |
0; 0 | — |
| SECONDARY Efficacy: Disease Control at Week 12 |
1; 3 | — |
| SECONDARY Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12 |
8.1; -1.5 | — |
| SECONDARY Efficacy: Target Lesion Size, Best Percentage Change From Baseline |
10.5; 0.2 | — |
| SECONDARY Efficacy: Progression-free Survival (PFS) |
6.1; 13.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01895946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.