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NCT01198028 · ClinicalTrials.gov registry record · Phase 2

Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma

A Phase 2 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
42
Enrollment target
1
Study location

NCT01198028: Completed Phase 2 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.

NCT01198028 is a Phase 2 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 42 participants, below the 58-participant average among 5 other Metastatic Skin Squamous Cell Carcinoma trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01198028, a Phase 2 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
42 participants
Enrollment target
1
Study location

Study Summary

This phase II trial studies how well erlotinib works in treating participants with skin squamous cell carcinoma that has spread to other places in the body or has come back. Drugs used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Primary Outcome

Overall response rate defined as the percentage of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by Response Evaluation Criteria in Solid Tumors 1.1A Bayesian design based on predictive probability will be implemented.

Interventions

  • DRUG Erlotinib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2011-03-10
Est. Completion 2019-05-01
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01198028 record still lists

NCT01198028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 58-participant average among 5 other Metastatic Skin Squamous Cell Carcinoma trials with a reported enrollment target (28% lower).

The record links to 2 conditions, with Metastatic Skin Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Erlotinib is the first listed.

NCT01198028 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01198028 about?

NCT01198028 is a clinical study titled "Erlotinib in Treating Patients With Recurrent or Metastatic Skin Squamous Cell Carcinoma". This phase II trial studies how well erlotinib works in treating participants with skin squamous cell carcinoma that has spread to other places in the body or has come back. Drugs used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor cells, either by killing the...

What is the current status of trial NCT01198028?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2011-03-10. Estimated completion is 2019-05-01.

What conditions does trial NCT01198028 study?

This clinical trial studies the following conditions: Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma.

What interventions are being tested in trial NCT01198028?

The interventions under investigation include: Erlotinib (DRUG).

Who is sponsoring clinical trial NCT01198028?

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

Where is trial NCT01198028 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT01198028, the US trial registry maintained by the National Library of Medicine. NCT01198028 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.