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
Principal Investigator
Charles Landen,
Status
Complete
Date Opened To Accrual
May 18 2016
Date Closed to Accrual
February 03 2020
Disease Site
Gynecologic [GY]
Ovarian
Phase
I/II
Developmental Therapeutics
Yes
Primary Objective
Phase I--Determine whether treatment with ruxolitinib in combination with conventional neoadjuvant and post-surgical chemotherapy is safe and tolerable in the primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Phase II--Demonstrate whether treatment with ruxolitinib in combination with conventional neoadjuvant and post-surgical chemotherapy results in a prolonged progression-free survival when compared to chemotherapy alone, in primary therapy for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Patient Population
Patients with clinically and radiographically suspected andpreviously untreated FIGO stage III or IV epithelial ovarian, primaryperitoneal or fallopian tube cancer, high grade, for whom the plan ofmanagement will include neoadjuvant chemotherapy with interval tumorreductive surgery who have undergone biopsies for histologic confirmation. The following histologic epithelial cell types are eligible: high gradeserous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or acombination of these.
Target Accrual
162
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.