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NCT01581970 · ClinicalTrials.gov registry record · Phase 2
Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01581970: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01581970 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01581970, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a feasibility study to assess the effectiveness of cetuximab when administered with low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and neck who have progressed on first line chemotherapy other than a cetuximab containing regimen will be treated with standard of care weekly cetuximab and twice daily low dose oral cyclophosphamide for 12 weeks.
Primary Outcome
The number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions.
Interventions
- DRUG Cyclophosphamide
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01581970 record still lists
NCT01581970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01581970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581970 about?
NCT01581970 is a clinical study titled "Potentiation of Cetuximab by Tregs Depletion With CSA in Advanced Head & Neck Cancer". This is a feasibility study to assess the effectiveness of cetuximab when administered with low dose oral cyclophosphamide. Patients with metastatic squamous cell cancer of head and neck who have progressed on first line chemotherapy other than a cetuximab containing regimen will be treated with sta...
What is the current status of trial NCT01581970?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01581970?
The interventions under investigation include: Cyclophosphamide (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01581970?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01581970's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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