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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|ClinicalTrials.gov Identifier: NCT02338349|
Recruitment Status : Recruiting
First Posted : January 14, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced ER+, HER2-Negative Breast Cancer||Drug: Elacestrant||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2019|
Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant.
Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D.
Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD.
Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history
- Dose Limiting Toxicities (DLT) [ Time Frame: The first 28 days of treatment. ]To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.
- Safety and Tolerability of Elacestrant (RAD1901) [ Time Frame: Up to 30 days after the end of treatment. ]Safety and tolerability will be assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values.
- Pharmacokinetics of Elacestrant (RAD1901) [ Time Frame: Every 28 days ]Plasma concentrations of RAD1901 will be assessed at predefined intervals
- Anti-Tumor Effect of Elacestrant (RAD1901) [ Time Frame: Every 8 weeks ]Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338349
|Contact: Janine McDermott||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Radius Pharmaceuticals, Inc.||Recruiting|
|Waltham, Massachusetts, United States, 02451|
|Contact: Study Director|