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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 : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 23, 2017
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03088527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2017)
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and 15 ]
    Maximum plasma concentration (Cmax)
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Day 1 and 15 ]
    Time to maximum plasma concentration (Tmax)
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1, First-in-Human Study of RAD140 in Postmenopausal Women With Breast Cancer
Official Title  ICMJE A Phase 1, First-in-Human, Multi-Part Study of RAD140 in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hormone Receptor Positive Malignant Neoplasm of Breast
Intervention  ICMJE Drug: RAD140
RAD140 will be supplied as formulated drug-in-capsules for oral administration.
Study Arms  ICMJE 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.

Intervention: Drug: RAD140
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 11, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2017)
40
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088527
Other Study ID Numbers  ICMJE RAD140-01-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radius Pharmaceuticals, Inc.
Study Sponsor  ICMJE Radius Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sr. Director, Clinical Operations Radius
PRS Account Radius Pharmaceuticals, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP