A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 (PEG-Irinotecan) When Given on a Q14 Day or a Q21 Day Schedule in Patients with Metastatic or Unresectable Locally Advanced Platinum-Resistant Ovarian Cancer

IRB-HSR# 14130
Service: Cancer, Women's Health | Category: Cancer (Oncology), Obstetrics/Gynecology
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Linda Duska, M.D.

Contact Information

Contact: Meredith Gross, C.R.C.
Phone: 434.924.2745
E-mail: mpg8b@virginia.edu

Clinical Trial Description

UVA Health System, Department of Obstetrics and Gynecology seeks: Women ages 18 and older with unresectable (cannot be removed by surgery) locally advanced or metastatic (meaning the cancer has spread) ovarian cancer which has not responded to prior treatment with other types of specific chemotherapy medications for research study.

The purpose of this study is to see if the experimental drug called NKTR-102 is safe and effective in treating patients with ovarian cancer. This study will also look at how your cancer responds to the study medication. It will look at the side effects of the study medication, and it will examine how long the study medication stays in your blood. The study involves blood draws, physical exams, pregnancy test, tests for heart function (electrocardiogram), CT/MRI scans and taking an experimental medicine. Depending on the study treatment you receive, your participation in this study will require approximately 17 or 26 study visits over one year. Each visit will last 3 to 4 hours. Your medical condition is followed every 3 months until completion of the study. 

Compensation

• Study-related medications are provided free of charge.
• Participant's insurance company will be billed for non-experimental medication, tests and procedures.
• No compensation is provided for this study.