Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2019-08-26
Target enrollment:
Participant gender:
Summary
This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously
treated metastatic colorectal cancer patients. This study will be conducted in two
components. First, patients will be enrolled in a phase I study of SGI-110 combined with
irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined,
patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and
irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
Astex Pharmaceuticals, Inc. Van Andel Research Institute