drugset / Trial / NCT01896856
Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer
Phase 1/2
Completed
118 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Astex Pharmaceuticals, Inc. · collabVan Andel Research Institute · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2013-10-23
- Primary completion
- 2019-08-26
- Completion
- 2019-08-26
Publications
- Lee V, Parkinson R, Zahurak M, Cope L, Cercek A, Verheul H, Gootjes E, Lenz HJ, Iqbal S, Jones P, Baylin S, Rami V, Ahuja N, El Khoueiry A, Azad NS. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS-102 in irinotecan-refractory metastatic colorectal cancer patients. Int J Cancer. 2024 May 15;154(10):1794-1801. doi: 10.1002/ijc.34845. Epub 2024 Feb 5.
- Sharma A, Vatapalli R, Abdelfatah E, Wyatt McMahon K, Kerner Z, A Guzzetta A, Singh J, Zahnow C, B Baylin S, Yerram S, Hu Y, Azad N, Ahuja N. Hypomethylating agents synergize with irinotecan to improve response to chemotherapy in colorectal cancer cells. PLoS One. 2017 Apr 26;12(4):e0176139. doi: 10.1371/journal.pone.0176139. eCollection 2017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guadecitabine | Oligonucleotide (other) | 30 mg/m2 | Subcutaneous |
| Subject | Guadecitabine | Oligonucleotide (other) | 45 mg/m2 | Subcutaneous |
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |
| Comparator | TAS-102 | Small molecule | 35 mg/m2 | Oral |
Indications
No indication recorded.