Full TitleA 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 (Version 1.8: 10-JUN-2016)
The drugs used to treat advanced colorectal cancer cause side effects. This study is assessing the safety and effectiveness of a new drug combination, SGI-110 and irinotecan, for previously treated metastatic colorectal cancer that continues to grow. Patients will be randomly assigned to receive either SGI-110 and irinotecan together, the drug regorafenib alone, or the drug TAS-102 alone.
SGI-110 is an investigational drug. It works by blocking DNA production in cancer cells. Irinotecan, regorafenib, and TAS-102 are all already approved to treat metastatic colorectal cancer.
SGI-110 is given as a subcutaneous (under the skin) injection, irinotecan is given intravenously (by vein), and regorafenib and TAS-102 are taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic colorectal cancer that has continued to grow despite irinotecan therapy.
- Patients may have had prior TAS-102 OR regorafenib treatment, but not both.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.