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NCT02508077 · ClinicalTrials.gov registry record · Phase 2
FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer
A Phase 2 study, sponsored by City of Hope Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02508077: Clinical Trial Phase 2 study, sponsored by City of Hope Medical Center.
NCT02508077 is a Phase 2 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508077, a Phase 2 study, was terminated before completion, sponsored by City of Hope Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF) wild-type genes, has spread from the original site of growth to another part of the body (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus irinotecan hydrochloride-based therapy, and who have failed at least one subsequent non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as panitumumab, may block tumor growth in different ways by targeting certain cells. Giving FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.
Primary Outcome
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance o
Interventions
- DRUG Fluorouracil
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Panitumumab
- DRUG Irinotecan Hydrochloride
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-02-16 |
| Est. Completion | 2017-09-13 |
| Phase | Phase 2 |
Why NCT02508077 stopped before completion
NCT02508077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT02508077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02508077 about?
NCT02508077 is a clinical study titled "FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer". This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF) wild-type genes, has spread from th...
What is the current status of trial NCT02508077?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2016-02-16. Estimated completion is 2017-09-13.
What interventions are being tested in trial NCT02508077?
The interventions under investigation include: Fluorouracil (DRUG), Laboratory Biomarker Analysis (OTHER), Panitumumab (BIOLOGICAL), Irinotecan Hydrochloride (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT02508077?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02508077's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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