Phase I Study of SGI-110 With Irinotecan Followed by Randomized Phase II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Previously Treated Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT01896856|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2013
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Previously Treated Metastatic Colorectal Cancer||Drug: SGI-110 Drug: Irinotecan Drug: regorafenib Drug: TAS-102||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 23, 2013|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Active Comparator: Phase 2: Arm B regorafenib or TAS-102
In phase 2, we will compare SGI-110 + irinotecan to regorafenib or TAS-102.
Other Name: lonsurf
Active Comparator: Phase 2: Arm A SGI-110 + irinotecan
In phase 2, we will compare SGI-110 + irinotecan to regorafenib or TAS-102
- Phase 1/2: SGI-110 + irinotecan versus regorafenib or TAS-102 adverse events [ Time Frame: 4 years ]In Phase 1, subjects will be assessed for adverse events attributable to SGI-110 and/or irinotecan. In Phase 2, subjects will be assessed for adverse events attributable to SGI-110 and/or irinotecan versus regorafenib or TAS-102.
- Phase 1/2: Response [ Time Frame: 4 ]Subjects will be monitored for response via RECIST 1.1 criteria.
- Phase 1/2: survival [ Time Frame: 4 years ]Subjects will be monitored for survival (overall survival versus progression free survival).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896856
|United States, California|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|VU Medisch Centrum|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Nilo Azad, MD||SKCCC at JHMI|