Recent Updates
Recently added Catalysts

fusidic acid

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Jan 15, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment201

FDA Designations

No designations recorded

Clinical trial landscape

fusidic acid · 1 trial · 1 indication

Phase 3 1
NCT00718315A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.Non-Small Cell Lung Cancer
COMPLETED201 Analytics
PHASE3COMPLETED
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Who Develop Skin Rash
30 Days

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").

Percentage of Participants With Skin Rash Stratified by Severity Grade
30 Days

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

Secondary Endpoints

Time to Appearance of Skin Rash
Days 0, 15, and 30
Percentage of Participants With Erythema
Days 0, 15, and 30
Percentage of Participants With Pruritus
Days 0, 15, and 30
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
erlotinib [Tarceva]DRUG150mg po daily
fusidic acid [Verutex]DRUGtopical, daily for 30 days.
erythromycin [Eritex]DRUGtopical, daily for 30 days.
FisiogelDRUGtopical, daily for 30 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

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...

Countries:Brazil
Unlock Eligibility Criteria

Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about fusidic acid

What is fusidic acid used for in Non-Small Cell Lung Cancer?

Fusidic acid is an investigational small molecule being studied for use in Non-Small Cell Lung Cancer (NSCLC). It is being evaluated in a Phase 3 clinical trial for the management of Tarceva-associated rash in patients with NSCLC. The drug is not yet approved and remains in clinical development.

What does fusidic acid target?

Fusidic acid is a small molecule antibiotic that works by inhibiting bacterial protein synthesis. In the context of the Phase 3 trial, it is being studied for its potential to manage skin rash associated with Tarceva (erlotinib) treatment in Non-Small Cell Lung Cancer patients. The specific molecular target in this oncology setting is not detailed.

Who makes fusidic acid?

Fusidic acid is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 3 clinical trial of the drug for Non-Small Cell Lung Cancer. Roche is responsible for the ongoing clinical development of fusidic acid.

What phase is fusidic acid in?

Fusidic acid is currently in Phase 3 clinical development. It is being studied in a completed Phase 3 trial for Non-Small Cell Lung Cancer, specifically for the management of Tarceva-associated rash. The drug is investigational and has not been approved for this indication.

What clinical trials is fusidic acid in?

Fusidic acid has one completed Phase 3 clinical trial registered as NCT00718315. This study, titled 'A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash,' enrolled 201 participants with Non-Small Cell Lung Cancer in Brazil. The trial was controlled but not double-blinded.

Is fusidic acid the same as Verutex?

Yes, fusidic acid is also known as Verutex. In the clinical trial NCT00718315, the drug is referred to as Verutex (Fusidic Acid). This alternative name is used in the study title for the management of Tarceva-associated rash in Non-Small Cell Lung Cancer patients.