Elacestrant for Central Nervous System Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gabrail Cancer Center, Canton, OH
Central Nervous System Diseases+9 More
Elacestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multi-site, global, open label study which includes a Phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a randomized Phase 2 evaluation of elacestrant alone or in combination with abemaciclib in women and men with brain metastases from ER positive, HER-2 negative breast cancer.

Eligible Conditions

  • Central Nervous System Diseases
  • Breast Cancer
  • Breast Diseases
  • Central Nervous System Neoplasms
  • Neoplasms by Site
  • Brain Diseases
  • Brain Cancer
  • Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Central Nervous System Diseases

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 3 years

1 year
The number of patients in the Phase 1b part of the study with any adverse events (AE).
3 years
Assess the efficacy of the drug combination of abemaciclib and elacestrant in the Phase 2 part of the study
Clinical Benefit Rate
Duration of Progression Free Survival
Duration of Tumor Response
Intracranial Response Rate per blinded independent central review (RANO)
Intracranial Response Rate per blinded independent central review (RECIST 1.1)

Trial Safety

Safety Progress

1 of 3

Other trials for Central Nervous System Diseases

Trial Design

5 Treatment Groups

Phase 2 Arm B
1 of 5
Phase 2 Arm A
1 of 5
Phase 1b Cohort 3
1 of 5
Phase 1b Cohort 1
1 of 5
Phase 1b Cohort 2
1 of 5
Active Control
Experimental Treatment

106 Total Participants · 5 Treatment Groups

Primary Treatment: Elacestrant · No Placebo Group · Phase 1 & 2

Phase 1b Cohort 3Experimental Group · 2 Interventions: Abemaciclib, Elacestrant · Intervention Types: Drug, Drug
Phase 1b Cohort 1Experimental Group · 2 Interventions: Abemaciclib, Elacestrant · Intervention Types: Drug, Drug
Phase 1b Cohort 2Experimental Group · 2 Interventions: Abemaciclib, Elacestrant · Intervention Types: Drug, Drug
Phase 2 Arm BActiveComparator Group · 2 Interventions: Abemaciclib, Elacestrant · Intervention Types: Drug, Drug
Phase 2 Arm A
Drug
ActiveComparator Group · 1 Intervention: Elacestrant · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1700
Elacestrant
2015
Completed Phase 1
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Closest Location: Gabrail Cancer Center · Canton, OH
Photo of ohio 1Photo of ohio 2Photo of ohio 3
2007First Recorded Clinical Trial
1 TrialsResearching Central Nervous System Diseases
112 CompletedClinical Trials

Who is running the clinical trial?

Stemline Therapeutics, Inc.Lead Sponsor
13 Previous Clinical Trials
1,183 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patient must have a signed informed consent form before any study-related activities.\n
You are a woman who is or has been menopausal or perimenopausal.
You have ER positive, HER-2 negative tumor status as confirmed by local laboratory testing.
HER-2 positive tumor with an IHC result of 2+ or 3+ for cellular membrane protein expression or an in situ hybridization positive result as defined in the 2013 or 2018 ASCO recommendations for HER 2 testing.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.