Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Seragon Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Seragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01823835
First received: March 25, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

Safety and pharmacokinetics (PK) study of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: ARN-810
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Seragon Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer

  • To determine the safety of ARN-810 and its O-glucuronide metabolite in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence of treatment-emergent adverse events will be summarized by severity and relationship to study drug. Clinical laboratory results, vital signs, use of concomitant medications and treatments, and endometrial thickness will be summarized with descriptive statistics (such as mean, median, standard deviation and range for continuous data, and percentages for categorical data).


Secondary Outcome Measures:
  • Pharmacokinetics (PK) of ARN-810 and its O-glucuronide metabolite [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Full plasma PK profiles (Cmax, Tmax, AUC, T1/2) will be obtained for ARN-810 and its O-glucuronide metabolite and analyzed using non-compartmental methods.


Estimated Enrollment: 72
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARN-810
During dose escalation, standard 3+3 design will be followed with a starting dose of 100 mg per day, followed by dose escalation to 200 mg, and by 200 mg increments thereafter. During dose expansion, two new cohorts of patients will be enrolled at the MTD/RP2D to further characterize the safety and pharmacokinetics of ARN-810.
Drug: ARN-810

Detailed Description:

Open-label, dose-finding study of ARN-810 administered orally on a continuous daily dosing regimen with a PK lead-in period . The incidence of dose limiting toxicity (DLT) will be evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total). Depending on safety and tolerability, patients will be assigned sequentially to escalating doses of ARN 810 using standard 3+3 design. All patients will be treated until disease progression, unacceptable toxicity, or patient withdrawal of consent.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
  2. ER-positive, HER2-negative
  3. At least 2 months must have elapsed from the use of tamoxifen
  4. At least 6 months must have elapsed from the use of fulvestrant
  5. At least 2 weeks must have elapsed from the use of any other anti-cancer hormonal therapy
  6. At least 4 weeks must have elapsed from the use of any chemotherapy
  7. Females, 18 years of age or older
  8. Postmenopausal status
  9. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

Key Exclusion Criteria:

  1. Untreated or symptomatic CNS metastases.
  2. Endometrial disorders
  3. More than 1 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred ≥ 12 months prior to enrollment)
  4. Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823835

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aditya Bardia, MD    617-643-2208    bardia.aditya@mgh.harvard.edu   
Principal Investigator: Aditya Bardia, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maura Dickler, MD    646-888-5456    dicklerm@mskcc.org   
Principal Investigator: Maura Dickler, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shireen Williams    615-875-6278    shireen.a.williams@vanderbilt.edu   
Principal Investigator: Ingrid A Mayer, MD         
Sponsors and Collaborators
Seragon Pharmaceuticals, Inc.
Investigators
Study Director: Edna Chow Maneval, PhD Seragon Pharmaceuticals
  More Information

No publications provided

Responsible Party: Seragon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01823835     History of Changes
Other Study ID Numbers: ARN-810-001
Study First Received: March 25, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seragon Pharmaceuticals, Inc.:
Locally Advanced or Metastatic ER+ Breast Cancer
Post-Menopausal
Oral ER antagonist

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014