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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 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 266 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01479465
The ClinicalTrials.gov registry entry for NCT01479465 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT01479465 reports 0 study locations.
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.
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