Back to resultsPhase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
Primary Purpose
Hormone Receptor Positive Malignant Neoplasm of Breast
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RAD140
Sponsored by
About this trial
This is an interventional treatment trial for Hormone Receptor Positive Malignant Neoplasm of Breast
Eligibility Criteria
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.
Sites / Locations
- Yale Cancer Center
- Cancer Center Protocol Office
- Barbara Ann Karmanos Cancer Center
- Washington University School of Medicine
- Sarah Cannon Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RAD140 Part A and Part B
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Number of adverse events related to study treatment
Number of adverse events related to study treatment
Number participants with dose interruptions and dose adjustments
Number participants with dose interruptions and dose adjustments
Secondary Outcome Measures
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC)
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.
Full Information
NCT ID
NCT03088527
First Posted
February 28, 2017
Last Updated
August 16, 2022
Sponsor
Stemline Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03088527
Brief Title
Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
Official Title
A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
September 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemline Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor Positive Malignant Neoplasm of Breast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RAD140 Part A and Part B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RAD140
Intervention Description
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
Primary Outcome Measure Information:
Title
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Description
Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment
Time Frame
First 28 days of treatment
Title
Number of adverse events related to study treatment
Description
Number of adverse events related to study treatment
Time Frame
Up to 30 days after end of treatment
Title
Number participants with dose interruptions and dose adjustments
Description
Number participants with dose interruptions and dose adjustments
Time Frame
Up to 30 days after end of treatment
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Maximum plasma concentration (Cmax)
Time Frame
Day 1 and 15
Title
Time to maximum plasma concentration (Tmax)
Description
Time to maximum plasma concentration (Tmax)
Time Frame
Day 1 and 15
Title
Area under the plasma concentration versus time curve (AUC)
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
Day 1 and Day 15
Title
Tumor response
Description
Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.
Time Frame
Screening and every 8 weeks for up to 12 months of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Director, Clinical Operations
Organizational Affiliation
Radius
Official's Role
Study Director
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cancer Center Protocol Office
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
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