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 : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : May 31, 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)|
|Actual Enrollment :||57 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338349
|United States, Massachusetts|
|Radius Pharmaceuticals, Inc.|
|Waltham, Massachusetts, United States, 02451|
|Study Director:||Sr. Director, Clinical Operations||Radius Pharmaceticals, Inc|