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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2020-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02650817

Metastatic Breast Cancer

COMPLETED PHASE1

Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer

NCT00052728

Breast Cancer

COMPLETED PHASE2

Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor

NCT05276713

Breast Cancer

UNKNOWN

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

NCT01702571

Breast Cancer

COMPLETED PHASE3

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

NCT00320385

Neoplasms, Breast

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hormone Receptor Positive Malignant Neoplasm of Breast

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

RAD140

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RAD140

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No