Clinical Trial: Phase I/IIA Study MK-3475 With Chemotherapy in Patients With Advanced GI Cancers
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase I/IIA Study of MK-3475 in Combination With Chemotherapy and Supplemental Celecoxib in Patients With Advanced GI Cancers (Colorectal/Appendiceal Adenocarcinoma, Gas
Brief Summary: This is a Phase I dose escalation trial to assess MTD of MK-3475 in combination with mFOLFOX6 followed by a Phase II expansion open label, nonrandomized trial with MK-3475 at MTD in combination with mFOLFOX6 and supplemental celecoxib in 4 cohorts of advanced/metastatic GI malignancies (pancreatic, gastro esophageal, colorectal/appendiceal adenocarcinoma and biliary carcinoma) to assess response rate, clinical benefit rate, progression free survival and overall survival. The Phase II expansion cohort will assess the effect of the addition of celecoxib to patients that do not respond to combination MK-3475/mFOLFOX treatment.
Detailed Summary:
Sponsor: University of Utah
Current Primary Outcome: Safety of combination mFOLFOX and MK-3475 [ Time Frame: Patient safety will be evaluated throughout the treatment period (treatment with MK-3475 and FOLFOX) which is expected to last 4-6 months for each patient. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Utah
Dates:
Date Received: October 15, 2014
Date Started: January 2015
Date Completion: January 2020
Last Updated: November 21, 2016
Last Verified: November 2016