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NCT01009203 · ClinicalTrials.gov registry record · Phase 2
Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma
A Phase 2 study, sponsored by New Mexico Cancer Research Alliance.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT01009203 is a Phase 2 study that was terminated before completion, run by New Mexico Cancer Research Alliance. The registered enrollment target is 13 participants.
The verdict
NCT01009203, a Phase 2 study, was terminated before completion, sponsored by New Mexico Cancer Research Alliance.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinical xenograft data. Patients will be treated with the combination of temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or cetuximab monotherapy.
Interventions
- DRUG Temsirolimus
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01009203
The ClinicalTrials.gov registry entry for NCT01009203 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Mexico Cancer Research Alliance, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.
NCT01009203 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01009203 about?
NCT01009203 is a clinical study titled "Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma". The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinica...
What is the current status of trial NCT01009203?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2009-12. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01009203?
The interventions under investigation include: Temsirolimus (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01009203?
This trial is sponsored by New Mexico Cancer Research Alliance, which has 66 total clinical trials registered on ClinicalTrials.gov.
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