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Ruxolitinib in Estrogen Receptor Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01594216
First received: May 7, 2012
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
This is a Phase II investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in combination with Exemestane in patients with estrogen-receptor positive advanced breast cancer. The objective of this study is to determine the preliminary safety and efficacy of the combination of exemestane and Ruxolitinib (INCB018424).

Condition Intervention Phase
Estrogen-receptor Positive Invasive Metastatic Breast Cancer
Drug: Ruxolitinib
Drug: Exemestane
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Of The JAK-Inhibitor Ruxolitinib (INCB018424) In Combination With Exemestane For Patients With Estrogen Receptor (ER) Positive Advanced Breast Cancer)

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First Stage
Ruxolitinib at 25 mg orally, twice daily and Exemestane, 25 mg orally once daily
Drug: Ruxolitinib Drug: Exemestane
Experimental: Second Stage
Ruxolitinib at 15 mg orally, twice daily and Exemestane, 25 mg orally once daily
Drug: Ruxolitinib Drug: Exemestane

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed, invasive metastatic breast cancer.
  • Estrogen-receptor positivity (defined by at least 5% staining by immunohistochemistry) on either the primary breast tumor or a metastatic biopsy.
  • Postmenopausal status, defined as: either "surgical menopause" via oophorectomy, or "natural menopause" in which the patient has had no menses in the previous 12-month period. Premenopausal patients who have been been rendered amenorrheaic by tamoxifen must have a serum estradiol level <30 pg/ml after discontinuation of tamoxifen. Amenorrheaic premenopausal subjects must have a negative pregnancy test during screening (prior to enrollment) and must be advised to use adequate contraception throughout their participation.
  • Prior therapy for the current malignancy: Patient must have 1) relapsed on or within 2 years of completing adjuvant hormonal therapy with a non-steroidal aromatase inhibitor, OR 2) failed a non-steroidal aromatase inhibitor in the metastatic setting. There is no limit to prior chemotherapy or hormonal regimens for this malignancy.
  • At least one measureable lesion by RECIST or mainly lytic bone lesions in the absence of measurable disease. Bone-only disease is allowed.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function, defined as follows:

Bilirubin ≤ 1.5 x the upper limit of normal (ULN) Serum creatinine ≤ 1.5 x UNL or calculated creatinine clearance ≥ 60 mL/min, and

  • For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
  • For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 5 x ULN
  • Adequate bone marrow function, defined as follows Absolute neutrophil count (ANC) >1500/mm3 Hemoglobin > 9 Platelets >100,000/mm3
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.

EXCLUSION CRITERIA:

  • Chemotherapy, hormonal therapy or investigational anti-tumor therapy within 21 days of starting study treatment. Use of bone-building agents is allowed.
  • Prior treatment with exemestane.
  • Any type of investigational agent within 28 days before the first dose of study treatment.
  • Unresolved clinically-meaningful toxicity due to prior therapy. Toxicity from previous treatment must be back to baseline or Grade ≤ 1, with the exception of neurotoxicity and alopecia.
  • Untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease. Patients who have stable disease after radiotherapy for CNS disease are eligible. Testing for brain involvement in the absence of symptoms is not required as part of this protocol.
  • Uncontrolled, intercurrent illness
  • Known ongoing or active infection, including active hepatitis B or hepatitis C. Testing for hepatitis B or C is not required as part of this protocol.
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months
  • A baseline corrected QT interval (QTc) > 470 ms.
  • The subject is known to be positive for the human immunodeficiency virus (HIV). Note: baseline HIV screening is not required
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  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: NCT01594216

Contacts
Contact: Angela DeMichele, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 10104
Contact: Angela DeMichele, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Angela DeMichele, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Angela DiMichele, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01594216     History of Changes
Other Study ID Numbers: UPCC 02112 
Study First Received: May 7, 2012
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Postmenopausal female

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Exemestane
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016