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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • BIOLOGICAL Cetuximab
  • OTHER Laboratory Biomarker Analysis
  • DRUG Temsirolimus

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2010-11
Est. Completion 2013-12
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01256385

The ClinicalTrials.gov registry entry for NCT01256385 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Cetuximab is the first listed.

NCT01256385 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.