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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650817
• Other study ID #: RAD1901-106
• Secondary ID: 2015-003555-22L5
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2016
• Est. completion date: October 18, 2019

Study information

• Verified date: August 2022
• Source: Stemline Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 18, 2019
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles
Belgium	UZ Leuven Campus Gasthuisberg	Leuven
Netherlands	Vrije Universiteit Medisch Centrum (VUMC)	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen (UMCG)	Groningen
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Stemline Therapeutics, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of ER Binding after RAD1901 treatment	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)	14 Days after the first dose
Secondary	Correlation of FES uptake after RAD1901 treatment to clinical response	To determine if any changes in ER binding, as observed through FES uptake, correlate with clinical response	Every 8 weeks for to up 12 months of treatment
Secondary	Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines	To determine if there is a tumor response to RAD1901 treatment	Every 8 weeks for to up 12 months of treatment
Secondary	Safety and Tolerability assessed in terms of adverse events, serious adverse events, ECG, physical examination, ECOG performance status, vital signs, and laboratory values	Characterization of the safety of RAD1901 in this patient population	Up to 30 days after the end of treatment
Secondary	Plasma concentrations of RAD1901 will be assessed at predefined intervals	Pharmacokinetic data will be collected.	Every 28 days for up to 3 cycles