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A phase II trial assessing Metronidazol Actavis 1% topical cream in the prevention and treatment of Erlotinib associated rash - MATER

A phase II trial assessing Metronidazol Actavis 1% topical cream in the prevention and treatment of Erlotinib associated rash - MATER

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002895-32-SE
Enrollment
Unknown
Registered
2007-07-12
Start date
2007-08-29
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erlotinib associated rash

Interventions

Trade Name: Metronidazol Actavis Pharmaceutical Form: Cream INN or Proposed INN: METRONIDAZOLE CAS Number: 443481 Concentration unit: % percent Concentration type: equal Concentration number: 1-

Sponsors

Roche AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-small cell lung cancer patients to start/on erlotinib treatment. Written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensitivity to metronidazole.

Design outcomes

Primary

MeasureTime frame
Main Objective: To identify whether metronidazole topical cream is effective in the prevention of erlotinib associated rash. To identify whether metronidazole topical cream is effective in the treatment of erlotinib associated rash.;Secondary Objective: Toxicity of metronidazole topical cream in erlotinib treatde patients.;Primary end point(s): To identify whether metronidazole topical cream is effective in the prevention and treatment of erlotinib associated rash.—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026