Phase 1
Completed N=135
Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of AZD2014
Source: ClinicalTrials.gov NCT01026402 ↗Enrolled (actual)
135
Serious AEs
40.7%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Best Objective Response |
0; 0; 2; 0; 0; 0 | — |
| SECONDARY Maximum Concentration (Cmax) Single Dose |
435; 1313; 1089; 1476; 4046; 2048 | — |
| SECONDARY Area Under the Curve (AUC) Single Dose |
1640; 5308; 3520; 8866; 20790; 11160 | — |
| SECONDARY Maximum Concentration (Cmax) at Steady State |
746.9; 1822; 1704; NA; 5517; 2730 | — |
| SECONDARY Area Under the Curve (AUC) at Steady State |
2984; 6436; 7532; NA; NA; 17230 | — |
| SECONDARY Urine PK - Fraction Dose Excreted (fe(0-12)) Single Dose |
0.3709; 0.5459; NA; 0.7094; 0.7728; 0.8344 | — |
| SECONDARY Urine PK - Fraction Dose Excreted (fe(0-12)) at Steady State |
NA; 0.9056; 1.026 | — |
| SECONDARY Urine PK - Renal Clearance (Renal CL) Single Dose |
0.07304; 0.03994; NA; 0.04338; 0.07526; 0.08576 | — |
| SECONDARY Urine PK - Renal Clearance (Renal CL) at Steady State |
0.03702; 0.04242; NA | — |
| SECONDARY Percent Change From Baseline in p4EBP1 at 2 Hours Post Dose |
-47.422; -31.067; -21.710; -78.760; -74.053; -66.855 | — |
| SECONDARY Percent Change From Baseline in pAKT (S473) in Platelet Rich Plasma (PRP) at 2 Hours Post Dose |
-63.633; -76.202; -65.375; -62.942; -67.349; -82.737 | — |
| SECONDARY Partial Metabolic Response (PMR), Cycle 1 |
0; 0; 4 | — |
| SECONDARY Partial Metabolic Response (PMR), Cycle 2 |
0; 0; 5 | — |
| SECONDARY Complete Metabolic Response (CMR), Cycle 1 |
0; 0; 0 | — |
| SECONDARY Complete Metabolic Response (CMR), Cycle 2 |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmation of a solid, malignant tumour that is refractory to standard therapies or for which no standard therapies exist
- At least one lesion (measurable and/or non-measurable) 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
- World Health Organisation performance status 0-2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Exclusion Criteria
- Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks prior to first dose of study drug
- Patients with abnormal fasting glucose, type I or uncontrolled type II diabetes
- Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions
Data sourced from ClinicalTrials.gov (NCT01026402). 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.