Overview

AZD9496 First Time in Patients Ascending Dose Study

Status:
Completed

Trial end date:
2019-04-03

Target enrollment:
0

Participant gender:
Female

Summary

This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of AZD9496

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AstraZeneca

Treatments:

Estrogens

Criteria

Inclusion Criteria: Provision of signed and dated, written informed consent prior to any
mandatory study specific procedures, sampling and analyses. Aged at least 18 years. Any
menopausal status. Pre- or peri-menopausal women must have commenced treatment with an LHRH
agonist at least 4 weeks prior to starting study treatment and must be willing to continue
to receive LHRH agonist therapy for the duration of the trial. Histological or cytological
confirmation of adenocarcinoma of the breast. ER-positive according to local laboratory;
HER-2 negative. Metastatic disease or locoregionally recurrent disease which is not
amenable to treatment with curative intent. Disease progression after at least 6 months of
endocrine therapy for ER+ breast cancer. Radiological or objective evidence of progression
on or after the last systemic therapy prior to starting study treatment. Receipt of ≤2
lines of prior chemotherapy for advanced disease. Females of child-bearing potential must
agree to use adequate contraceptive measures, must not be breast feeding and must have a
negative pregnancy test prior to start of dosing. Eastern Cooperative Oncology Group (ECOG)
performance status 0-1 with no deterioration over the previous 2 weeks and minimum life
expectancy of 12 weeks.

Exclusion Criteria: Any cytotoxic chemotherapy, investigational agents or other anti-cancer
drugs for the treatment of advanced breast cancer from a previous treatment regimen or
clinical study within 14 days of the first dose of study treatment. Any unresolved
toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events
(CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia.
Presence of life-threatening metastatic visceral disease, uncontrolled central nervous
system metastatic disease or symptomatic pulmonary lymphangitic spread. Any evidence of
severe or uncontrolled systemic diseases, including uncontrolled hypertension, active
bleeding diatheses, or active infection. Unexplained symptomatic endometrial disorders.
Uncontrolled symptomatic thyroid dysfunction. Inadequate bone marrow reserve or organ
function