drugset / Trial / NCT02041429

Ruxolitinib W/ Preop Chemo For Triple Negative Inflammatory Brca

NCT02041429

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This phase I/II research study is evaluating a combination of drugs called paclitaxel and ruxolitinib as a possible treatment for inflammatory breast cancer. Ruxolitinib is a newly discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that may be important in cancer, including breast cancer. Blocking this pathway may stop cancer cells from growing. Ruxolitinib has been approved by the FDA for patients with bone marrow disease, and this is the first study using this drug in combination with paclitaxel for breast cancer. Paclitaxel (also called Taxol) is an FDA drug approved for breast cancer patients. Paclitaxel works by blocking the small microtubules inside cancer cells and preventing cell growth. Information from laboratory experiments suggests that ruxolitinib might also have effects on breast cancer.These studies have shown that ruxolitinib may make paclitaxel more effective.

Timeline

Start
2014-02
Primary completion
2016-05
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Ruxolitinib Small molecule 10 mg Oral
Subject Ruxolitinib Small molecule 15 mg Oral
Subject Ruxolitinib Small molecule 20 mg Oral
Subject Ruxolitinib Small molecule 25 mg Oral

Indications