AZD9496 First Time in Patients Ascending Dose Study

Study identifier:D6090C00001

ClinicalTrials.gov identifier:NCT02248090

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women with Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer

Medical condition

ER+ HER2- Advanced Breast Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD9496

Sex

Female

Actual Enrollment

45

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 22 Oct 2014
Primary Completion Date: 31 Jan 2017
Study Completion Date: 03 Apr 2019

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2020 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria