Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT02338349
Interventions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Radius Pharmaceuticals, Inc., Waltham, Massachusetts, United States
Contact Details
Name: Sr. Director, Clinical Operations
Affiliation: Radius Pharmaceticals, Inc
Role: STUDY_DIRECTOR
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