Recurrent Rectal Cancer Clinical Trial
Official title:
A Phase 2 Open-Label Study of RO4929097 in Metastatic Colorectal Cancer
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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