drugset / Trial / NCT02640755

Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase

NCT02640755

Phase 1 Completed 4 enrolled AstraZeneca Quintiles, Inc. · collab
Non-randomizedParallel-groupOpen-labelOther

Summary

This Phase 1, open label, single centre, non-randomised study in patients with advanced solid malignancies consists of two parts: 1. Single Dose Period - will characterise the absorption, metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\]AZD2014 from the body 2. Multiple Dose Period - will further assess the safety and tolerability and anti-tumour activity of multiple doses of AZD2014 when given as a monotherapy or given in combination with paclitaxel or fulvestrant.

Timeline

Start
2016-01-28
Primary completion
2016-12-21
Completion
2017-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Paclitaxel Small molecule 80 mg/m2
Subject Vistusertib Small molecule 50 mg Oral
Subject Vistusertib Small molecule 125 mg Oral

Indications