- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
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Waltham, Massachusetts, United States, 02451
- Radius Pharmaceuticals, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Patients must be post-menopausal women, as defined in the protocol
- 18 years or older
- Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
- Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
- Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor
Note: This list is not complete. Further inclusion criteria is provided in the protocol synopsis.
Key Exclusion Criteria:
Prior anticancer or investigational drug treatment within the following windows:
- Tamoxifen therapy less than 14 days before first dose of study treatment
- Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
- Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
- Any chemotherapy less than 28 days before first dose of study
- Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
- Patients with untreated or symptomatic central nervous system (CNS) metastases
- Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts
Note: This list is not complete. Further exclusion criteria is provided in the protocol synopsis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elacestrant
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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The first 28 days of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 30 days after the end of treatment.
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Pharmacokinetics of Elacestrant (RAD1901)
Time Frame: Every 28 days
|
Plasma concentrations of RAD1901 will be assessed at predefined intervals
|
Every 28 days
|
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.
|
Every 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sr. Director, Clinical Operations, Radius Pharmaceticals, Inc
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAD1901-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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