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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

October 23, 2013

Primary Completion Date

August 26, 2019

Study Completion Date

August 26, 2019

Conditions
Previously Treated Metastatic Colorectal Cancer
Interventions
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

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

90033

USC / Norris Comprehensive Cancer Center, Los Angeles

1081 HV

VU Medisch Centrum, Amsterdam

Sponsors
All Listed Sponsors
collaborator

Van Andel Research Institute

OTHER

collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER