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

March 20, 2012
July 8, 2014
June 2012
May 2015   (final data collection date for primary outcome measure)
Objective response by RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Objective response by RECIST 1.1
Same as current
Complete list of historical versions of study NCT01562873 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Ruxolitinib in Patients With Breast Cancer
Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Ruxolitinib
Taken orally, twice daily
Other Name: INCB018424
Experimental: Treatment Arm
Ruxolitinib
Intervention: Drug: Ruxolitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
41
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01562873
12-024
Yes
Nancy Lin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Not Provided
Dana-Farber Cancer Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP