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An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Edna Chow Maneval, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Aragon Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

ARN-810-001

NCT ID:

NCT01823835

Start Date:

March 2013

Completion Date:

December 2016

Related Keywords:

  • Breast Cancer
  • Locally Advanced or Metastatic ER+ Breast Cancer
  • Post-Menopausal
  • Oral ER antagonist
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Massachusetts General HospitalBoston, Massachusetts  02114-2617