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

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ClinicalTrials.gov Identifier: NCT02650817
Recruitment Status : Active, not recruiting
First Posted : January 8, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

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
Metastatic Breast Cancer Drug: RAD1901 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: Elacestrant (formerly RAD1901)
To receive daily oral elacestrant
Drug: RAD1901
RAD1901, a novel selective ER degrader (SERD)
Other Name: Elacestrant




Primary Outcome Measures :
  1. Effect of ER Binding after RAD1901 treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Every 28 days for up to 3 cycles ]
    Pharmacokinetic data will be collected.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Tamoxifen or fulvestrant therapy < 42 days before 1st 18FES-PET scan
    2. Any other anti-cancer endocrine therapy < 14 days before 1st dose of study drug
    3. Any chemotherapy < 28 days before 1st dose of study drug
    4. 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

Information from the National Library of Medicine

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): NCT02650817


Locations
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 1000
UZ Leuven Campus Gasthuisberg
Leuven, Belgium, 3000
Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.
Investigators
Principal Investigator: Elisabeth GE de Vries, MD Universitair Medisch Centrum Groningen (UMCG)

Responsible Party: Radius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02650817     History of Changes
Other Study ID Numbers: RAD1901-106
2015-003555-22 ( EudraCT Number )
L54809.042.15 ( Other Identifier: ABR nr )
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs