AZD9496 First Time in Patients Ascending Dose Study
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
1 other identifier
interventional
45
3 countries
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2014
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2019
CompletedJune 24, 2019
June 1, 2019
2.3 years
September 22, 2014
June 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
Safety and tolerability in terms of adverse events, serious adverse events (including death) and safety measures: ECG, physical examination, vital signs and laboratory variables. Definition of maximum tolerated dose (MTD) or maximum feasible dose (MFD) by measuring the number of evaluable patients with dose-limiting toxicities.Time frame DLT period 28 days
Routine safety assessments, throughout the period that patients receive AZD9496 up to 28 days following discontinuation of last dose of study treatment.
Secondary Outcomes (3)
Single and multiple dose pharmacokinetics of AZD9496
12 weeks
4β-hydroxycholesterol concentration in blood
12 weeks
Antitumour activity
every 8 weeks for 24 weeks and then every 12 weeks thereafter until disease progression
Study Arms (1)
AZD9496
EXPERIMENTALAZD9496 dose escalation and expansion(s)
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Research Site
New York, New York, 10065, United States
Sarah Cannon
Nashville, Tennessee, 37203, United States
Seoul National Univ. Hospital
Seoul, 110-744, South Korea
Research Site
Cambridge, CB2 0QQ, United Kingdom
Christie
Manchester, M20 4BX, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Erika Hamilton
Nashville Hospital, United States
- STUDY DIRECTOR
Justin Lindemann
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2014
First Posted
September 25, 2014
Study Start
October 22, 2014
Primary Completion
January 31, 2017
Study Completion
April 3, 2019
Last Updated
June 24, 2019
Record last verified: 2019-06