Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Breast Neoplasms

Liver Diseases

Gastrointestinal Diseases

A single oral dose of 200 mg elacestrant (2 x 100 mg tablets).

Elacestrant dihydrochloride

Stemline Trials

This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.

A total of 16 subjects will be recruited and divided between the following two Groups:

Group 1: 8 subjects with severe hepatic impairment Group 2: 8 subjects with normal hepatic function (control group)

On Day 1, subjects will receive a single oral dose of 200 mg Elacestrant (2 x 100 mg tablets). Safety assessment and blood sampling for Elacestrant analysis on plasma will be performed at predefined time points up to 240 hours post.

The total duration of study participation for each subject (from screening to the follow up call) is anticipated to be approximately 6 weeks.

A Pharmacokinetic Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

A Phase 1, Open-Label, Non-randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Oral Dose of 200 mg Elacestrant in Subjects With Normal Hepatic Function or Severe Hepatic Impairment

Stemline Therapeutics, Inc.

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Mitogens

Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Samuraciclib capsules by mouth once a day

Samuraciclib

Elacestrant Dihydrochloride

Clinical Operations

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer

Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level.

Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results

Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.

Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from enrolment until disease progression, or death due to any cause.

ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1.

ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment.

DOR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1

Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions

Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pharmacokinetic Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function	NCT06126575	Hepatic Impairm...	Elacestrant dih...	18 Years -	Stemline Therapeutics, Inc.
A Pharmacokinetic Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function	NCT06126575	Hepatic Impairm...	Elacestrant dih...	18 Years -	Stemline Therapeutics, Inc.
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer	NCT05963997	Metastatic Brea... Locally Advance... Breast Cancer	Samuraciclib Elacestrant Dih...	18 Years -	Carrick Therapeutics Limited

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