CGX1321-101 (Gastrointestinal Cancer)
What is the Purpose of this Study?
If you choose to join this study, you will:
-Take the study drug, CGX1321, by mouth once a day
-Take zoledronic acid by I.V. once every 6 or 8 weeks
-Take daily supplements of vitamin D3 and calcium carbonate
-Give blood and urine samples
-Have regular CT or MRI scans
In addition, some people may also get pembrolizumab by I.V. once every 3 weeks.
-Take the study drug, CGX1321, by mouth once a day
-Take zoledronic acid by I.V. once every 6 or 8 weeks
-Take daily supplements of vitamin D3 and calcium carbonate
-Give blood and urine samples
-Have regular CT or MRI scans
In addition, some people may also get pembrolizumab by I.V. once every 3 weeks.
What is the Condition Being Studied?
Gastrointestinal Cancer
Who Can Participate in this Study?
Adults with advanced gastrointestinal cancer who:
-Failed, refused, or are unsuited for standard-of-care treatment
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to see if the study drug, CGX1321, is safe and effective for fighting cancer.
Study Details
Full Title
[CGX1321-101] A Phase 1 Open-label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects with Advanced Solid Tumors and Phase 1b Study of CGX1321 in Combination with Pembrolizumab in Subjects with Advanced Gastrointestinal Tumors
Principal Investigator
Protocol Number
IRB:
PRO00102442
NCT:
NCT02675946
ClinicalTrials.gov
View on ClinicalTrials.gov