Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)
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ClinicalTrials.gov Identifier: NCT05563220 |
Recruitment Status :
Recruiting
First Posted : October 3, 2022
Last Update Posted : April 8, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | September 22, 2022 | ||||||||
First Posted Date ICMJE | October 3, 2022 | ||||||||
Last Update Posted Date | April 8, 2024 | ||||||||
Actual Study Start Date ICMJE | January 24, 2023 | ||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Determine the recommended Phase 2 dose (RP2D) of elacestrant in combination with each of the other study drugs [ Time Frame: 18 months ] The recommended Phase 2 dose (RP2D) will be determined as the dose that is associated with less than 33% of patients (</+ 1 patient out of 6) experiencing a dose-limiting toxicities (DLTs) during the first cycle.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer | ||||||||
Official Title ICMJE | A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer | ||||||||
Brief Summary | This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. | ||||||||
Detailed Description | This is a multicenter, Phase 1b/2 trial. The Phase 1b aims at selecting the RP2D dose, defined as a dose that is associated with less than 33% of patients experiencing a DLT of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib, that is, ≤1 patient experiencing a DLT out of 6 DLT evaluable patients. For each combination, this phase will have between 1 and 3 cohorts of 6 DLT-evaluable patients each. The total number of DLT-evaluable patients in all the combinations will vary between 24 and 72. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. The treatment arms will be:
Phase 1b will have a total of 90 patients, while Phase 2 will have 310 patients for all treatment arm combinations. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
400 | ||||||||
Original Estimated Enrollment ICMJE |
322 | ||||||||
Estimated Study Completion Date ICMJE | August 31, 2026 | ||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Additional Eligibility for the Alpelisib Combination (Phase 1b and Arm A) Inclusion: In general, the SmPC of the respective combination drug should be consulted for instructions/restrictions with respect to interactions with concomitant medications.
Exclusion:
Additional Eligibility for the Everolimus Combination (Phase 1b and Arm B) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor. Exclusion:
Additional Eligibility for the Abemaciclib Combination (Arm C) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor. Exclusion:
Additional Eligibility for the Ribociclib Combination (Phase 1b and Arm C) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor. Exclusion:
Additional Eligibility for the Palbociclib Combination (Phase 1b) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting, one of which was in combination with a CDK4/6 inhibitor. Exclusion:
Additional Eligibility for the Palbociclib Combination (Arm D) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting. Exclusion:
Additional Eligibility for the Abemaciclib Combination (Arm D) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting. Exclusion:
Additional Eligibility for Ribociclib Combination (Arm D) Inclusion: 1. One or up to two prior hormonal therapies in the advanced or metastatic setting. Exclusion:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05563220 | ||||||||
Other Study ID Numbers ICMJE | STML-ELA-0222 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Stemline Therapeutics, Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Stemline Therapeutics, Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Stemline Therapeutics, Inc. | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |