RO4929097 in Treating Patients With Metastatic Colorectal Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01116687
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	May 2010
Completion date	March 2012

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