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Trial record 1 of 4 for:    rad1901
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A Phase IB Study to Evaluate the Effect of RAD1901 on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radius Health, Inc.
ClinicalTrials.gov Identifier:
NCT02650817
First received: January 6, 2016
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to visualize and quantify ER-binding sites during treatment with RAD1901

Condition Intervention Phase
Metastatic Breast Cancer Drug: RAD1901 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • 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) [ Time Frame: 14 Days after the first dose ]

Secondary Outcome Measures:
  • Correlation of FES uptake after RAD1901 treatment to clinical response [ Time Frame: Every 8 weeks for to up 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 for to up 12 months of treatment ]
  • 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 ]
  • Plasma concentrations of RAD1901 will be assessed at predefined intervals [ Time Frame: Every 28 days for up to 12 months of treatment ]

Estimated Enrollment: 16
Study Start Date: December 2015
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD1901 Drug: RAD1901
RAD1901, a novel selective ER degrader (SERD)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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. 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Health, Inc.
  More Information

Responsible Party: Radius Health, 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 )
Study First Received: January 6, 2016
Last Updated: April 12, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017