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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: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study: 1. grade 4 thrombocytopenia lasting \>7days 2. any grade 3-4 febrile neutropenia 3. grade 3 or higher non-hematologic toxicity unless it could be managed by supportive treatment 4. any other clinically significant adverse event which would place subjects at undue safety risk, or result
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 |
What the finished NCT01896856 record still lists
NCT01896856 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 5 interventions - of which Regorafenib is the first listed.
NCT01896856 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01896856's enrollment target sits among peer trials
118 499th of 2000 higher than 1,502 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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