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NCT01267240 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01267240: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01267240 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01267240, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving capecitabine together with vorinostat is more effective than capecitabine alone in treating patients with cancer of the head and neck cancer.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
Interventions
- DRUG Capecitabine
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-12 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
Why NCT01267240 stopped before completion
NCT01267240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT01267240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01267240 about?
NCT01267240 is a clinical study titled "Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer". This partially randomized phase II trial studies giving capecitabine and vorinostat in treating patients with head and neck cancer that has come back after previous treatment or that has spread to other areas in the body. Drugs used in chemotherapy, such as capecitabine, work in different ways to st...
What is the current status of trial NCT01267240?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-12. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01267240?
The interventions under investigation include: Capecitabine (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01267240?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01267240's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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