Ruxolitinib in Patients With 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.
|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|
- Objective response by RECIST 1.1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]Objective response by RECIST 1.1
- 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
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
Taken orally, twice daily
Other Name: INCB018424
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562873
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|