Ruxolitinib in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01562873
• Other study ID #: 12-024
• Status: Terminated
• Phase: Phase 2
• First received: March 20, 2012
• Last updated: November 25, 2015
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Ruxolitinib
Taken orally, twice daily

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response by RECIST 1.1	Objective response by RECIST 1.1	2 years	No
Secondary	Toxicity Profile	Describe the grade and frequency of adverse events according to CTCAE v4.0 in patients treated with ruxolitinib	2 years	Yes
Secondary	Clinical Benefit Rate	CR+PR+SD greater than or equal to 24 weeks	2 years	No
Secondary	Progression-Free Survival	Describe progression-free survival (time from study entry to progression or death, whichever comes first)	2 years	No
Secondary	Overall survival	Describe overall survival (time from study entry to death due to any cause) in study participants	2 years	No