Absorption, metabolism, excretion and pharmacokinetics of a single dose [14C]AZD2014 followed by a multiple dose phase - 14C

Study identifier:D2270C00015

ClinicalTrials.gov identifier:NCT02640755

EudraCT identifier:2015-000198-11

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Non-randomised, Single Centre Study of the Absorption, Metabolism, Excretion and Pharmacokinetics of AZD2014 After a Single Oral Dose of [14C]AZD2014, Followed by Multiple Doses of AZD2014 Either As Monotherapy or In Combination With Either Fulvestrant or Paclitaxel in Patients With Advanced Solid Malignancies

Medical condition

solid malignancies

Phase

Phase 1

Healthy volunteers

No

Study drug

[14C]AZD2014, Multiple dose AZD2014, Fulvestrant, Paclitaxel

Sex

All

Actual Enrollment

4

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Jan 2016
Primary Completion Date: 21 Dec 2016
Study Completion Date: 06 Jul 2017

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Jan 2019 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Quintiles

Inclusion and exclusion criteria