A Phase 2 Open-Label Study of RO4929097 in Metastatic Colorectal Cancer
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.
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).
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
Number of Participants With Objective Radiographic Response (ORR)
To determine the objective radiographic response rate associated with RO4929097 in patients with metastatic colorectal cancer who have progressed following at least 2 prior treatments in the metastatic setting. Radiologic assessment of tumor burden (CT scans of the chest, abdomen and pelvis, or MRI of the abdomen and pelvis and CT of the chest) was scheduled every 8 weeks. Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were used for evaluation of the primary endpoint.
2 months from enrollment for each participant
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|