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NCT01479465 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma
A Phase 2 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 266
- Enrollment target
NCT01479465: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.
NCT01479465 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 266 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01479465, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 266 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.
Primary Outcome
The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Irinotecan
- BIOLOGICAL Simtuzumab
- DRUG Placebo to match SIM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
Why NCT01479465 stopped before completion
NCT01479465 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT01479465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01479465 about?
NCT01479465 is a clinical study titled "Efficacy and Safety of Simtuzumab (SIM) With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma". The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal ade...
What is the current status of trial NCT01479465?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 266 participants. The study started on 2011-12. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01479465?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), Simtuzumab (BIOLOGICAL), Placebo to match SIM (DRUG).
Who is sponsoring clinical trial NCT01479465?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01479465's enrollment target sits among peer trials
266 209th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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