Clinical Trials /

Ruxolitinib in Estrogen Receptor Positive Breast Cancer

NCT01594216

Description:

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ruxolitinib in Estrogen Receptor Positive Breast Cancer
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: UPCC 02112
  • NCT ID: NCT01594216

Conditions

  • Estrogen-receptor Positive Invasive Metastatic Breast Cancer

Interventions

DrugSynonymsArms
RuxolitinibFirst Stage
ExemestaneFirst Stage

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).

Trial Arms

NameTypeDescriptionInterventions
First StageExperimentalRuxolitinib at 25 mg orally, twice daily and Exemestane, 25 mg orally once daily
  • Ruxolitinib
  • Exemestane
Second StageExperimentalRuxolitinib at 15 mg orally, twice daily and Exemestane, 25 mg orally once daily
  • Ruxolitinib
  • Exemestane

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Adverse Events
Time Frame:3
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Trial Keywords

  • Postmenopausal female

Last Updated

September 23, 2016