Clincosm LogoSign in Get a demo

Phase IB Study to Evaluate RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

Sponsor
Stemline Therapeutics, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT02650817
Collaborator
(none)
16
Enrollment
5
Locations
1
Arm
42.5
Actual Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901)

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The purpose of this study is to visualize and quantify ER-binding sites during treatment with Elacestrant (RAD1901) using 16α-18F-Fluoro-17β-estradiol (FES) positron emission tomography (PET) imaging

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IB Study to Evaluate the Effect of RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer Lesions Using 16α-18F-Fluoro-17β-Estradiol Positron Emission Tomography Imaging
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Oct 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Elacestrant (formerly RAD1901)

To receive daily oral elacestrant

Drug: RAD1901
RAD1901, a novel selective ER degrader (SERD)
Other Names:
  • Elacestrant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of ER Binding after RAD1901 treatment [14 Days after the first dose]

      To determine the effect of RAD1901 treatment on the estrogen receptor (ER) expression and estradiol binding to the ER in lesions from patients with metastatic breast cancer (mBC)

    Secondary Outcome Measures

    1. Correlation of FES uptake after RAD1901 treatment to clinical response [Every 8 weeks for to up 12 months of treatment]

      To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response

    2. Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines [Every 8 weeks for to up 12 months of treatment]

      To determine if there is a tumor response to RAD1901 treatment

    3. Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values [Up to 30 days after the end of treatment]

      Characterization of the safety of RAD1901 in this patient population

    4. Plasma concentrations of RAD1901 will be assessed at predefined intervals [Every 28 days for up to 3 cycles]

      Pharmacokinetic data will be collected.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Patients with histologically-proven, ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced, inoperative, and/or mBC

    2. Tumor progression after ≥ 6 months of at least 1 line of hormonal systemic treatment (SERM, SERD, or aromatase inhibitor) in the metastatic setting

    3. Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1 or clinically evaluable disease

    4. Greater than or equal to 18 years of age

    5. Patients must be post-menopausal

    6. Life expectancy >3 months

    Key Exclusion Criteria:

    1. Greater than 3 lines of endocrine therapy for metastatic disease.

    2. Prior anti-cancer treatment or investigational drug therapy within the following windows:

    3. Tamoxifen or fulvestrant therapy < 42 days before 1st 18FES-PET scan

    4. Any other anti-cancer endocrine therapy < 14 days before 1st dose of study drug

    5. Any chemotherapy < 28 days before 1st dose of study drug

    6. Any investigational drug therapy < 28 days or 3 half-lives (whichever is longer) prior to the 1st dose of study drug 2. Patients with untreated or symptomatic central nervous system (brain) metastases 3. Patients with known endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding, or cysts

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Jules Bordet Bruxelles Belgium 1000
    2 UZ Leuven Campus Gasthuisberg Leuven Belgium 3000
    3 Vrije Universiteit Medisch Centrum (VUMC) Amsterdam Netherlands
    4 Universitair Medisch Centrum Groningen (UMCG) Groningen Netherlands
    5 Erasmus Medical Center Rotterdam Netherlands

    Sponsors and Collaborators

    • Stemline Therapeutics, Inc.

    Investigators

    • Principal Investigator: Elisabeth GE de Vries, MD, Universitair Medisch Centrum Groningen (UMCG)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stemline Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02650817
    Other Study ID Numbers:
    • RAD1901-106
    • 2015-003555-22
    • L54809.042.15
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022