ELEVATE
Research type
Research Study
Full title
A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)
IRAS ID
1007543
Contact name
Jennifer Neu Ott
Contact email
Sponsor organisation
Stemline Therapeutics Inc.
Eudract number
2022-002609-10
Clinicaltrials.gov Identifier
Research summary
This research study is being done to find out if elacestrant (a medication intended to get rid of cancer cells or stop their growth) is safe and tolerable when given in combination with one of the following medications: alpelisib, everolimus, palbociclib, abemaciclib, or ribociclib. Researchers will also look at what effect the study medication has on your tumour(s).
This study has two parts. The first part is called “dose escalation” which is designed to determine the highest tolerable dose of the study medication elacestrant in combination with one of the following alpelisib, everolimus, palbociclib, abemaciclib or ribociclib. Doses will increase for each new group until the highest tolerable dose is reached. The second part of the study is called “Dose Expansion”. The purpose is to determine if elacestrant in combination with the other mentioned medications might be an effective treatment option for people with certain types of metastatic breast cancer.
Elacestrant is an investigational medication. This means that the European Medicines Agency has not approved elacestrant, but allows it to be used only in research studies like this study.
Although alpelisib, everolimus, palbociclib, abemaciclib or ribociclib are approved for certain types of cancer the combination of elacestrant with either these drugs is not approved by the European Medicines Agency which is why it is considered investigational.
During this study, researchers will:
Determine the highest tolerable dose of elacestrant in combination with one of the other study medications;
Find out if elacestrant in combination with one of the other study medications is safe
Assess how the study medications stop or slow your tumour from growing.
Measure the levels of the study medications in your blood (pharmacokinetics).
Assess what the study medications do to the tumour markers that can be measured in your blood (pharmacodynamics) that are related to development and growth of your tumours.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0097
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion