Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metronidazole Actavis · 1 trial · 1 indication
Severity of the rash was evaluated semi-quantitatively using the scale of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
Severity of the rash was evaluated semi-quantitatively using the scale of CTCAE v3.0. Grade 0: no rash; Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening or disabling; Grade 5: Death related to rash. Same participant may be counted in more than one reported categories.
| Arm | Type | Description |
|---|---|---|
| Prevention (Erlotinib + Metronidazole Actavis) | EXPERIMENTAL | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated at the same day as the start of erlotinib. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
| Treatment (Erlotinib + Metronidazole Actavis) | EXPERIMENTAL | Participants will receive erlotinib orally daily. Metronidazole actavis treatment will be initiated when participants develop rash. Metronidazole actavis 1% topical cream will be applied on the right side of the face and chest twice daily for 4 weeks. Left side of the face and chest was treated according to local standard procedures (ie, with non-active moisturizing cream). |
| Name | Type | Description |
|---|---|---|
| Erlotinib | DRUG | Participants will receive erlotinib 150 milligrams (mg) orally daily for 4 weeks. |
| Metronidazole Actavis | DRUG | Metronidazole actavis 1% topical cream will be applied on the face and chest twice daily for 4 weeks. |
| Non-active Moisturizing Cream | OTHER | Left side of the face and chest will be treated according to local standard procedures (ie, with non-active moisturizing cream). |
Inclusion Criteria: * non-small cell lung cancer * eligible to start treatment with erlotinib Exclusion Criteria: * hypersensitivity to metronidazole
Metronidazole Actavis is a small molecule drug developed by Roche Holding AG. It has been studied in oncology, specifically in patients with non-squamous non-small cell lung cancer. Its clinical development reached Phase 2, and it is not an approved cancer therapy.
Metronidazole Actavis was studied in non-squamous non-small cell lung cancer for the prevention and treatment of rash associated with Tarceva (erlotinib) therapy. The Phase 2 trial enrolled 34 patients with this condition in Sweden. It is an investigational use, not an established approved indication.
Metronidazole Actavis is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical research evaluating the drug in non-squamous non-small cell lung cancer patients receiving Tarceva (erlotinib).
Metronidazole Actavis reached Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for the studied oncology indication.
Metronidazole Actavis was evaluated in one completed Phase 2 trial, NCT00642473, titled A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash. The trial enrolled 34 patients with non-squamous non-small cell lung cancer in Sweden and used a controlled design.
The single Phase 2 trial of Metronidazole Actavis, NCT00642473, was a controlled study that enrolled 34 participants aged 18 years and older of all sexes. It was not randomized and not double blind, and it enrolled patients with non-squamous non-small cell lung cancer in Sweden.