NCT01192763

RO4929097 Before Surgery in Treating Patients With Pancreatic Cancer

A Neoadjuvant Pharmacodynamic Study Of RO4929097 (RO) in Pancreas Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects of RO4929097 before surgery in treating patients with pancreatic cancer. RO4929097 may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Giving RO4929097 before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the effects of neoadjuvant gamma-secretase inhibitor RO4929097 on Notch inhibition via interrogation of Hes-1 expression in patients with pancreatic cancer. SECONDARY OBJECTIVES: I. To evaluate the effects of this regimen on pancreatic cancer stem cell self-renewal and tumorigenesis as compared to pancreatic stem cells from controls (patients who do not receive treatment). II. To evaluate the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral gamma-secretase inhibitor RO4929097 on days 1-3 and 8-10 in the absence of disease progression or unacceptable toxicity. Beginning 7 days after completion of gamma-secretase inhibitor RO4929097, patients undergo complete resection comprising pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy based on the anatomic location of the cancer. Tumor tissue from biopsy and surgery and blood samples are collected periodically for pharmacodynamic studies. After completion of study therapy, patients are followed up every 6 months for 1 year.

Conditions

• Adenocarcinoma of the Pancreas
• Stage IA Pancreatic Cancer
• Stage IB Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gamma-secretase/Notch signalling pathway inhibitor RO4929097	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
PROCEDURE	neoadjuvant therapy
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-01-01
• First posted: 2010-09-01
• Last updated: 2013-09-30

Locations

6 sites across 1 country: United States