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NCT01059305 · ClinicalTrials.gov registry record · Phase 2

Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT01059305: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01059305 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01059305, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken before and after radiation and/or surgery can help to control aggressive cutaneous squamous cell carcinoma. The safety of the drug will also be studied.

Primary Outcome

Response Evaluation Criteria In Solid Tumors (RECIST) criteria for CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, and NE = inevaluable. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): \>30% decrease in sum of diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): \>20% increas

Interventions

  • DRUG Erlotinib

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2011-02
Est. Completion 2016-03
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT01059305 stopped before completion

NCT01059305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.

NCT01059305 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01059305 about?

NCT01059305 is a clinical study titled "Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin". The goal of this clinical research study is to learn if Tarceva ® (erlotinib) when taken before and after radiation and/or surgery can help to control aggressive cutaneous squamous cell carcinoma. The safety of the drug will also be studied.

What is the current status of trial NCT01059305?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-02. Estimated completion is 2016-03.

What interventions are being tested in trial NCT01059305?

The interventions under investigation include: Erlotinib (DRUG).

Who is sponsoring clinical trial NCT01059305?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01059305's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT01059305, the US trial registry maintained by the National Library of Medicine. NCT01059305 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.