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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

March 25, 2013
August 22, 2013
March 2013
March 2015   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01823835 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

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

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: ARN-810
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.
Intervention: Drug: ARN-810
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2016
March 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT01823835
ARN-810-001
No
Seragon Pharmaceuticals, Inc.
Seragon Pharmaceuticals, Inc.
Not Provided
Study Director: Edna Chow Maneval, PhD Seragon Pharmaceuticals
Seragon Pharmaceuticals, Inc.
August 2013

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