Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer

Hormone Receptor Positive Malignant Neoplasm of Breast Clinical Trial

Official title:

A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088527
• Other study ID #: RAD140-01-001
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2017
• Est. completion date: September 24, 2020

Study information

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

Clinical Trial Summary

The primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Description:

This is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (PK) characteristics of RAD140 in hormone receptor positive breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 24, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Progressive metastatic or locally advanced or metastatic breast cancer.

• Clinically confirmed as postmenopausal.

• Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 at screening.

Key Exclusion Criteria:

• HER2 positive patients by local laboratory testing.

• Triple negative breast cancer.

• Any chemotherapy within the 28 days prior to the first dose of study drug.

• Any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known.

• Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug.

• Fulvestrant within 30 days prior to first dose of study drug.

• Any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter.

• Radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study.

• Known history of human immunodeficiency virus infection (HIV) or hepatitis C or active hepatitis B infection, unless the patient was diagnosed >10 years prior to enrollment and no evidence of active liver disease.

• Currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin), oxymetholone, danazol, fluoxymesterone (Halotestin), or testosterone-like agents.

• Untreated or uncontrolled brain metastasis.

• Diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin.

• Pregnant and nursing females.

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor Positive Malignant Neoplasm of Breast
• Neoplasms

Intervention

Drug:
• RAD140
RAD140 will be supplied as formulated drug-in-capsules for oral administration.

Locations

Country	Name	City	State
United States	Cancer Center Protocol Office	Boston	Massachusetts
United States	Barbara Ann Karmanos Cancer Center	Detroit	Michigan
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Stemline Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment	Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment	First 28 days of treatment
Primary	Number of adverse events related to study treatment	Number of adverse events related to study treatment	Up to 30 days after end of treatment
Primary	Number participants with dose interruptions and dose adjustments	Number participants with dose interruptions and dose adjustments	Up to 30 days after end of treatment
Secondary	Maximum plasma concentration (Cmax)	Maximum plasma concentration (Cmax)	Day 1 and 15
Secondary	Time to maximum plasma concentration (Tmax)	Time to maximum plasma concentration (Tmax)	Day 1 and 15
Secondary	Area under the plasma concentration versus time curve (AUC)	Area under the plasma concentration versus time curve (AUC)	Day 1 and Day 15
Secondary	Tumor response	Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.	Screening and every 8 weeks for up to 12 months of treatment