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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088527
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Stemline Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Malignant Neoplasm of Breast Drug: RAD140 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : September 24, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment [ Time Frame: First 28 days of treatment ]
    Incidence rate of dose-limiting toxicities (DLTs) RAD140 treatment

  2. Number of adverse events related to study treatment [ Time Frame: Up to 30 days after end of treatment ]
    Number of adverse events related to study treatment

  3. Number participants with dose interruptions and dose adjustments [ Time Frame: Up to 30 days after end of treatment ]
    Number participants with dose interruptions and dose adjustments


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and 15 ]
    Maximum plasma concentration (Cmax)

  2. Time to maximum plasma concentration (Tmax) [ Time Frame: Day 1 and 15 ]
    Time to maximum plasma concentration (Tmax)

  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 and Day 15 ]
    Area under the plasma concentration versus time curve (AUC)

  4. Tumor response [ Time Frame: Screening and every 8 weeks for up to 12 months of treatment ]
    Clinical benefit rate (CBR) or objective response rate (ORR) will be assessed by Investigators per RECIST v1.1 along with time-related efficacy endpoints.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088527


Locations
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United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06510
United States, Massachusetts
Cancer Center Protocol Office
Boston, Massachusetts, United States, 02114
United States, Michigan
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Stemline Therapeutics, Inc.
Investigators
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Study Director: Sr. Director, Clinical Operations Radius
More Information
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Responsible Party: Stemline Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03088527    
Other Study ID Numbers: RAD140-01-001
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases