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NRG-GY007

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/Co-Principal Investigator

Robert A. Burger, M.D./Charles N. Landon, Jr., M.D.

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 must have clinically and radiographically suspected and previously untreated FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation. Patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these. All patients must have measurable disease as defined by RECIST 1.1.  

Target Accrual

Phase I: approximately 32; Phase II: 130

Status

Amendment 3: March 20, 2017

Amendment 2: January 9, 2017

Amendment 1: October 10, 2016

Activated: May 18, 2016

Protocol Documents

The protocol and related documents are available at NRG-GY007 (Enter CTEP IAM credentials to access NRG Oncology Member Login)

 

 


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Copyright 2017 by NRG Oncology