GY007 A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of the Phase I portion of this study is to test the safety and side effects of a study drug called Ruxolitinib. Different doses of Ruxolitinib will be studied to see which dose is safe and well tolerated with standard doses of carboplatin and paclitaxel.
You are being asked to take part in this study because you have ovarian, fallopian tube or peritoneal cancer which has spread beyond the pelvis.
Participants in the Phase I part of the trial will be assigned to one of six groups with different starting doses of Ruxolitinib, and different starting doses of carboplatin commonly used in clinical practice. Participants will get Ruxolitinib, carboplatin and paclitaxel for 3 cycles. Then study participants will have surgery to remove tumor tissue, followed by 3 more cycles of Ruxolitinib, carboplatin and paclitaxel. Ruxolitinib will then be continued alone following completion of the sixth/last cycle of carboplatin and paclitaxel. The first several study participants will receive the lowest dose of ruxolitinib and carboplatin. If the drugs do not cause serious side effects, they will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered. You will receive paclitaxel, carboplatin and the study drug Ruxolitinib for three 21-day cycles, followed by tumor reduction surgery. You will then receive paclitaxel, carboplatin and the study drug Ruxolitinib for three more 21-day cycles. You will then receive Ruxolitinib alone. You will continue to receive study treatment unless your cancer worsens, you develop a medical condition or side effect that makes it unsafe to continue, or you decide to stop treatment. Your doctor will continue to watch you for side effects and follow your condition every three months for one year after completion of your treatment with Ruxolitinib.
03/05/2019 05:03 AM