NCT01175343

RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase II Study of RO4929097 in Advanced Platinum Resistant Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying the side effects and how well RO4929097 works in treating patients with recurrent and/or metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the antitumor activity of RO4929097 in recurrent and / or metastatic epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer by progression free survival rate at the end of 4 cycles. SECONDARY OBJECTIVES: I. To assess the antitumor activity of RO4929097 through secondary endpoints including: overall response rate and CA125 response rate (GCIC criteria). II. To assess the safety of single agent RO4929097 in advanced platinum resistant ovarian, fallopian tube and primary peritoneal cancers. III. To explore expression of Notch biomarkers in advanced platinum resistant ovarian, fallopian, and primary peritoneal cancers. IV. To explore the impact of RO49097 on ascitic fluid circulating tumor cells. OUTLINE: This is a multicenter study. Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected. After completion of study therapy, patients are followed up every month for at least 1 year.

Conditions

• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Stage IV Fallopian Tube Cancer
• Stage IV Ovarian Cancer
• Stage IV Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Gamma-Secretase Inhibitor RO4929097	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-10-01
• Completion: 2015-08-01
• First posted: 2010-08-04
• Last updated: 2017-05-24
• Results posted: 2017-05-24

Locations

12 sites across 2 countries: United States, Canada