NCT01116687

RO4929097 in Treating Patients With Metastatic Colorectal Cancer

A Phase 2 Open-Label Study of RO4929097 in Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well RO4929097 works in treating patients with metastatic colorectal 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 determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least two prior treatments in the metastatic setting. SECONDARY OBJECTIVES: I. To determine the progression-free survival (PFS) and overall survival (OS) associated with this agent. II. To determine the safety and tolerability of RO4929097 in this patient population. III. To assess whether response correlates with up regulation of the Notch pathway, to be determined through immunohistochemical analysis of Notch1, ICN and HES1 on available paraffin-embedded tissue samples (exploratory aim). OUTLINE: Participants will take 20 mg of RO4929097 by mouth at home in the morning for 3 days and then not take it for 4 days, continuously. The tablet is to be taken at approximately the same time the days they take it on an empty stomach, 1 hour before a meal or 2 hours after a meal. Participants will be asked to keep a "pill diary" recording each dose of study drug (including missed, skipped, or vomited doses) and return the diary to the study staff each visit. Participants will be informed that tablets should not be broken or opened; that they should avoid eating grapefruits or drinking grapefruit juice while on the study; that if they miss a dose of study drug, they should not try to make up that dose; that instead, they should wait until their next scheduled dose. Participants will see their study doctor and undergo standard blood work (approximately 12 mL) every 4 weeks. During these visits, participants will be asked about side effects of the RO4929097 and undergo a physical examination. Participants will continue taking the RO4929097 as long as they are tolerating it and as long as the cancer is shrinking or remains stable.

Conditions

• Recurrent Colon Cancer
• Recurrent Rectal Cancer
• Stage IV Colon Cancer
• Stage IV Rectal Cancer

Interventions

Type	Name	Description
DRUG	gamma-secretase/Notch signalling pathway inhibitor RO4929097	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-05-01
• Completion: 2012-03-01
• First posted: 2010-05-05
• Last updated: 2014-05-20
• Results posted: 2012-06-11

Locations

1 site across 1 country: United States