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NCT01256385 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT01256385: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01256385 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01256385, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.
Primary Outcome
Progression determined using RECIST criteria: \>=20% increase in the sum of the longest diameters of target lesions from nadir, occurrence of new lesions, or progression of non-target lesions.
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01256385 record still lists
NCT01256385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.
NCT01256385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01256385 about?
NCT01256385 is a clinical study titled "Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy". This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some o...
What is the current status of trial NCT01256385?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2010-11. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01256385?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG).
Who is sponsoring clinical trial NCT01256385?
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 NCT01256385's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 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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