NCT02338349

A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.

Detailed description

The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of elacestrant in patients with advanced ER+HER2-negative breast cancer. The secondary objectives of this study are: * To assess the safety and tolerability of elacestrant * To evaluate the pharmacokinetics (PK) of elacestrant * To evaluate the preliminary anti-tumor effect of elacestrant

Conditions

• Advanced ER+, HER2-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Elacestrant

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-09-01
• Completion: 2020-04-01
• First posted: 2015-01-14
• Last updated: 2022-08-18

Locations

1 site across 1 country: United States