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 Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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 RAD1901, the incidence of Dose Limiting toxicities (DLTs) will be assessed during the first 28 days.
- Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, vital signs, and laboratory values [ 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.
- Plasma concentrations of RAD1901 will be assessed at predefined intervals. [ Time Frame: Every 28 days for up to 12 months of treatment. ]
- Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines. [ Time Frame: Every 8 weeks until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months of treatment. ]
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD1901.
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 the evaluate the safety, tolerability, and PK of a tablet dosage form.
Part D, Dose Exploration: Additional dose exploration of higher doses of the tablet dosage form based on initial PK findings or alternative dosing schedules may be conducted.
The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RAD1901 in patients with advanced ER+HER2-negative breast cancer.
The secondary objectives of this study are:
- To assess the safety and tolerability of RAD1901
- To evaluate the pharmacokinetics (PK) of RAD1901
- To evaluate the preliminary anti-tumor effect of RAD1901
Please refer to this study by its ClinicalTrials.gov identifier: NCT02338349
|United States, Massachusetts|
|Radius Pharmaceuticals, Inc.|
|Waltham, Massachusetts, United States, 02451|