NCT01896856

Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

A Phase I Study of SGI-110 Combined With Irinotecan Followed by a Randomized Phase II Study of SGI-110 Combined With Irinotecan Versus Regorafenib or TAS-102 in Previously Treated Metastatic Colorectal Cancer Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Previously Treated Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	SGI-110 Dose Escalation	* Dose level 1 (DL1): 45 mg/m\^2 administered as a subcutaneous injection * Dose level 1G (DL1G): 45 mg/m\^2 administered as a subcutaneous injection + growth factor support * Dose level -1 (DL-1): 30 mg/m\^2 administered as a subcutaneous injection * Dose level -1G (DL-1G): 30 mg/m\^2 administered as a subcutaneous injection + growth factor support
DRUG	Regorafenib	160 mg taken orally
DRUG	TAS-102	35 mg/m\^2 taken orally
DRUG	SGI-110	45 mg/m\^2 administered as a subcutaneous injection
DRUG	Irinotecan	125 mg/m\^2 administered IV

Timeline

• Start date: 2013-10-23
• Primary completion: 2019-08-26
• Completion: 2019-08-26
• First posted: 2013-07-11
• Last updated: 2020-10-06
• Results posted: 2020-09-14

Locations

4 sites across 2 countries: United States, Netherlands