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Ruxolitinib in Estrogen Receptor Positive Breast Cancer

Information source: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Estrogen-receptor Positive Invasive Metastatic Breast Cancer

Intervention: Ruxolitinib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Abramson Cancer Center of the University of Pennsylvania

Official(s) and/or principal investigator(s):
Angela DiMichele, MD, Principal Investigator, Affiliation: Abramson Cancer Center of the University of Pennsylvania

Overall contact:
Angela DeMichele, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com

Summary

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). A maximum of 25 people will be enrolled on this study at the University of Pennsylvania.

Clinical Details

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)

Study design: Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Primary outcome: Number of Adverse Events

Detailed description: Abstract Brief abstract (250 words or less) describing the study in language understandable to a lay person. Include brief description of the purpose, target disease/condition if applicable, key eligibility criteria, and main study interventions 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). A maximum of 25 people will be enrolled on this study at the University of Pennsylvania. As part of this study, subjects have the option of providing separate consent for research related biopsies (at baseline and Cycle 1/Day 22). If they provide consent, subjects will be co-enrolled on a separate sample acquisition research study under the direction of Dr. Angela DeMichele (IRB #811841/UPCC#17110: Collection of Tumor Tissue, Blood and Clinical Data from Patients with Advanced Breast Cancer (short name TRACR-MET)) through which these biopsies will be performed with Radiology support. The study team will review this separate consent with the study subjects considering participation in this optional component so that they can make a fully educated decision regarding whether or not they would like to participate.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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 amenorrheic by tamoxifen must have a serum estradiol level 30 pg/ml after discontinuation of tamoxifen. Amenorrheic 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 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.

- Patient must have one measurable lesion by RECIST criteria. Bone-only disease is not

allowed.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ and bone marrow function

- 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.

- 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 including, but not limited to:

- 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) greater than 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.

Locations and Contacts

Angela DeMichele, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 10104, United States; Recruiting
Angela DeMichele, MD, Phone: 855-216-0098, Email: PennCancerTrials@emergingmed.com
Angela DeMichele, MD, Principal Investigator
Additional Information

Starting date: April 2012
Last updated: January 13, 2015

Page last updated: August 23, 2015

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