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Also known as fusidic acid [Verutex]
fusidic acid · 1 trial · 1 indication
Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| erlotinib [Tarceva] | DRUG | 150mg po daily |
| fusidic acid [Verutex] | DRUG | topical, daily for 30 days. |
| erythromycin [Eritex] | DRUG | topical, daily for 30 days. |
| Fisiogel | DRUG | topical, daily for 30 days |
Inclusion Criteria: * adult patients, \>=18 years of age; * locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV); * eligible to start treatment with Tarceva, or receiving Tarceva for \<=5 days. Exclusion Criteria: * presence of skin rash or other signs of skin toxicity; * tre...
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Fusidic acid is being studied in Non-Small Cell Lung Cancer for the management of Tarceva-associated rash, a skin side effect of the lung cancer therapy erlotinib. The Phase 3 trial evaluated it alongside erythromycin and Fisiogel in patients receiving Tarceva. It is not a direct anticancer treatment in this setting.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with fusidic acid in this oncology program. The Phase 3 study was conducted in Brazil. Roche is the company name investors and analysts track for this asset.
Fusidic acid reached Phase 3 for managing Tarceva-associated rash in Non-Small Cell Lung Cancer. The single registered trial, NCT00718315, is listed as completed, and no active trials are currently recorded. It remains an investigational use in this oncology setting rather than an approved indication.
The trial is NCT00718315, titled A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash. It was a Phase 3, randomized, controlled study that enrolled 201 patients aged 18 years and older in Brazil. The trial is completed.
Yes, Verutex is an alternative brand name for fusidic acid. The Phase 3 trial in Non-Small Cell Lung Cancer is listed under the Verutex name, so searches for either term refer to the same small molecule. Fusidic acid is also widely known as a topical antibiotic in other settings.
The Phase 3 trial NCT00718315 enrolled 201 patients. It was randomized and controlled, though not double blind, and included both male and female participants aged 18 years and older. Enrollment was conducted in Brazil, and the study is now completed.