MATER Study: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Small Cell Lung Cancer
Intervention: erlotinib [Tarceva] (Drug); metronidazole actavis 1% topical cream (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Overall contact:
Please reference Study ID Number: RLI_ML21308, Phone: 973-235-5000
Summary
This study will evaluate the efficacy and safety of metronidazole actavis 1% topical cream in
the prevention and treatment of rash associated with Tarceva treatment, in patients with
non-small cell lung cancer. The first cohort of patients enrolled in the study will be
treated twice daily with metronidazole cream on the right side of the face and upper thorax,
the same day as they start treatment with Tarceva (150mg po daily). The corresponding body
parts on the left side are treated according to local standard procedures (ie with non-active
moisturising cream). The second cohort of Tarceva-treated patients will only receive twice
daily treatment with metronidazole cream if and when they develop rash. In both cohorts,
efficacy will be evaluated at week 2 and week 4. The anticipated time on metronidazole
treatment is <3 months, and the target sample size is <100 individuals.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Frequency and intensity of Tarceva-associated rash (CTC AE v3.0)
Secondary outcome: Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients, >=18 years of age;
- non-small cell lung cancer;
- eligible to start treatment with Tarceva.
Exclusion Criteria:
- hypersensitivity to metronidazole.
Locations and Contacts
Please reference Study ID Number: RLI_ML21308, Phone: 973-235-5000
MALMOE 20502, Sweden; Recruiting
GOETEBORG 41345, Sweden; Recruiting
LUND 22185, Sweden; Recruiting
STOCKHOLM S-14186, Sweden; Recruiting
UMEA S-901 85, Sweden; Recruiting
VAXJO 35185, Sweden; Recruiting
Additional Information
Starting date: February 2008
Ending date: February 2009
Last updated: October 15, 2008
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