Ruxolitinib in Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01562873
First received: March 20, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This research study is a Phase II clinical trial. Phase II trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved ruxolitinib for your type of cancer.

Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Ruxolitinib
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: Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Objective response by RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Objective response by RECIST 1.1


Secondary Outcome Measures:
  • Toxicity Profile [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Describe the grade and frequency of adverse events according to CTCAE v4.0 in patients treated with ruxolitinib

  • Clinical Benefit Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    CR+PR+SD greater than or equal to 24 weeks

  • Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Describe progression-free survival (time from study entry to progression or death, whichever comes first)

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Describe overall survival (time from study entry to death due to any cause) in study participants


Estimated Enrollment: 41
Study Start Date: June 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Ruxolitinib
Drug: Ruxolitinib
Taken orally, twice daily
Other Name: INCB018424

Detailed Description:

Tumor tissue will be tested for the presence of the pStat3 marker. Patients with a positive test will be potentially eligible for study treatment (ruxolitinib). Patients with a negative test will not be eligible to join the treatment portion of the study.

Participants with breast cancer that is accessible to a biopsy will undergo a research biopsy procedure prior to beginning ruxolitinib. This biopsy is required as part of study participation so research doctors can learn more about pSTAT3 as a marker for breast cancer.

Participatns will be given a drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 4 weeks, during which time the study drug will be taken by mouth twice a day every day beginning on cycle 1 day 1.

During all cycles participants will undergo a physical exam, be asked questions about their general health, be askd specific questions about any problems that they might be having and any medications they may be taking.

Participants will also undergo blood tests, have tumor markers drawn, be asked to complete health-realted questionnaires, and undergo body scans to assess the effects of ruxolitinib on your tumor(s).

Partipant's medical condition will be followed for up to 2 years following study completion. This will happen through medical record reviews as well as phone calls to the participant or partipants' doctor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer
  • Must have known ER, PR and HER2 status
  • Either, Triple Negative Metastatic Breast Cancer or
  • Inflammatory Breast Cancer with any ER, PR HER2 status
  • Availability of archival tissue specimen suitable for pStat3 testing
  • Life expectancy of greater than 3 months
  • Measurable disease by RECIST
  • At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
  • For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Active brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
  • Clinically significant malabsorption syndrome
  • Concurrent use of medications/substances that are strong inhibitors of CY3A4
  • No uncontrolled intercurrent illness
  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: NCT01562873

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Nancy Lin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01562873     History of Changes
Other Study ID Numbers: 12-024
Study First Received: March 20, 2012
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
pSTAT3+

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014