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

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

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.

Study Overview

• Status: Completed
• Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast
• Intervention / Treatment: Drug: RAD140

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Cancer Center Protocol Office
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: RAD140 Part A and Part B; Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of RAD140. Part B, Safety Expansion: Once the maximum tolerated dose (MTD) has been identified and/or a recommended dose escalation (RDE) has been determined, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary clinical activity of the recommended dose.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment	Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment	First 28 days of treatment
Number of adverse events related to study treatment	Number of adverse events related to study treatment	Up to 30 days after end of treatment
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	Maximum plasma concentration (Cmax)	Day 1 and 15
Time to maximum plasma concentration (Tmax)	Time to maximum plasma concentration (Tmax)	Day 1 and 15
Area under the plasma concentration versus time curve (AUC)	Area under the plasma concentration versus time curve (AUC)	Day 1 and Day 15
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

Collaborators and Investigators

• Sponsor: Stemline Therapeutics, Inc.
• Investigators: Study Director: Sr. Director, Clinical Operations, Radius

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): September 24, 2020

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: RAD140-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No