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

NCT02640755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-04-22

Study results available
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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.

Conditions

  • Solid Malignancies

Interventions

DRUG

[14C]AZD2014

Radiolabelled dual TORC1/TORC2 inhibitor

DRUG

Multiple dose AZD2014

Dual TORC1/TORC2 inhibitor

DRUG

Fulvestrant

Hormonal Agent

DRUG

Paclitaxel

Taxane

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Emma Dean, MD · The Christie NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02640755 on ClinicalTrials.gov