NRG-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

Principal Investigator

Charles Landen,

Status

Closed to Accrual

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