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NCT01896856 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
NCT01896856 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 118 participants.
The verdict
NCT01896856, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
Study 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).
Interventions
- DRUG Regorafenib
- DRUG Irinotecan
- DRUG TAS-102
- DRUG SGI-110
- DRUG SGI-110 Dose Escalation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2013-10-23 |
| Est. Completion | 2019-08-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01896856
The ClinicalTrials.gov registry entry for NCT01896856 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Regorafenib is the first listed.
NCT01896856 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01896856 about?
NCT01896856 is a clinical study titled "Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer". 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. Aft...
What is the current status of trial NCT01896856?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2013-10-23. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT01896856?
The interventions under investigation include: Regorafenib (DRUG), Irinotecan (DRUG), TAS-102 (DRUG), SGI-110 (DRUG), SGI-110 Dose Escalation (DRUG).
Who is sponsoring clinical trial NCT01896856?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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