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MATER An Open Label Study to Assess the Effect of Metronidazole Actavis 1% Topical Cream in the Prevention and Treatment of Tarceva-associated Rash in Patients With Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

MATER An Open Label Study to Assess the Effect of Metronidazole Actavis 1% Topical Cream in the Prevention and Treatment of Tarceva-associated Rash in Patients With Non-small Cell Lung Cancer


Inclusion Criteria:



- adult patients, >=18 years of age;

- non-small cell lung cancer;

- eligible to start treatment with Tarceva.

Exclusion Criteria:

- hypersensitivity to metronidazole.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and intensity of Tarceva-associated rash (CTC AE v3.0)

Outcome Time Frame:

At baseline, and after 2 and 4 weeks of metronidazole treatment (prevention cohort); at baseline, at appearance of rash, and after 2 and 4 weeks of metronidazole treatment (treatment cohort).

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Sweden: Central Ethics Committee, Stockholm

Study ID:

ML21308

NCT ID:

NCT00642473

Start Date:

February 2008

Completion Date:

March 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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