34 Participants Needed

Vismodegib for Basal Cell Carcinoma

SO
Overseen BySy Olson-Mcpeek
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to compare how well tolerated and effective four different dosing schedules (two personalized, intermittent dosing schedules as compared to a fixed intermittent and continuous dosing regimen) work in people with advanced basal cell carcinoma.

Will I have to stop taking my current medications?

The trial requires that you do not take statins or St. John's Wort while participating. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is Vismodegib safe for humans?

Vismodegib has been shown to cause side effects like muscle spasms, hair loss, taste changes, weight loss, fatigue, nausea, and more. It is also known to be a teratogen, meaning it can cause birth defects, so it should not be used during pregnancy.12345

How is the drug Vismodegib unique in treating basal cell carcinoma?

Vismodegib is unique because it is the first drug to inhibit the Hedgehog pathway, which is crucial in the development of basal cell carcinoma. It is specifically used for cases that are advanced and cannot be treated with surgery or radiation.12467

What data supports the effectiveness of the drug Vismodegib for treating basal cell carcinoma?

Vismodegib has been shown to be effective in treating advanced basal cell carcinoma, with an overall response rate of 30.3% in patients with metastatic BCC and 42.9% in those with locally advanced BCC. The drug works by inhibiting the hedgehog pathway, which is involved in the development of this type of skin cancer.12347

Who Is on the Research Team?

Zeynep Eroglu | Moffitt

Zeynep Eroglu

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

Adults with advanced basal cell carcinoma can join this trial. They must be able to measure their tumor, have not used hedgehog inhibitors in the last 6 months, and have good liver, kidney, and bone marrow function. Pregnant or nursing women cannot participate; men and women must use contraception.

Inclusion Criteria

My liver, kidneys, and bone marrow are functioning well.
I have had treatments for basal cell carcinoma, including hedgehog inhibitors over 6 months ago.
Must have ability to comprehend and the willingness to sign written informed consent for study participation.
See 7 more

Exclusion Criteria

Inability or unwillingness to swallow capsules.
I am not pregnant, do not plan to become pregnant, and am not nursing.
Any known allergy, hypersensitivity or severe reaction to vismodegib or any of the ingredients
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vismodegib with different dosing schedules: continuous, fixed intermittent, or personalized intermittent based on TGI model or adaptive model.

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vismodegib
Trial Overview The study is testing four different dosing schedules of Vismodegib on patients with advanced basal cell carcinoma: two personalized intermittent doses compared to a fixed intermittent dose and a continuous regimen.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D: Personalized Intermittent Vismodegib (TGI model)Experimental Treatment1 Intervention
Group II: Arm C: Personalized Intermittent Vismodegib (Adaptive)Experimental Treatment1 Intervention
Group III: Arm B: Fixed Intermittent VismodegibExperimental Treatment1 Intervention
Group IV: A: Continuous VismodegibActive Control1 Intervention

Vismodegib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Erivedge for:
🇪🇺
Approved in European Union as Erivedge for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

In a real-world study of 63 patients with locally advanced or metastatic basal cell carcinoma (BCC), vismodegib demonstrated a high objective response rate (ORR) of 73%, with 57% achieving a partial response and 16% achieving a complete response.
While vismodegib was effective, 76.2% of patients experienced at least one adverse event, with common side effects including muscular spasms and dysgeusia, and serious adverse events occurred in 17% of patients, highlighting the need for careful monitoring during treatment.
Efficacy and safety profile of vismodegib in a real-world setting cohort of patients with advanced basal cell carcinoma in Argentina.Cozzani, R., Del Aguila, R., Carrizo, M., et al.[2021]
Erivedge (vismodegib) was approved by the FDA for treating recurrent, locally advanced, or metastatic basal cell carcinoma (BCC) based on a trial showing an overall response rate of 30.3% in metastatic cases and 42.9% in locally advanced cases, with median response durations of 7.6 months for both groups.
The treatment was generally well-tolerated, though common side effects included muscle spasms, alopecia, and fatigue; however, it is important to note that vismodegib is a potent teratogenic agent, indicating significant safety considerations for pregnant patients.
U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma.Axelson, M., Liu, K., Jiang, X., et al.[2022]
Vismodegib (Erivedge) is an effective treatment for advanced basal cell carcinoma, targeting the Hedgehog signaling pathway that is often overactive in this type of skin cancer.
Clinical studies have demonstrated that Vismodegib can lead to significant tumor shrinkage and improved outcomes for patients with advanced cases, highlighting its role as a key therapeutic option.
Vismodegib (erivedge) for advanced Basal cell carcinoma.Fellner, C.[2023]

Citations

Efficacy and safety profile of vismodegib in a real-world setting cohort of patients with advanced basal cell carcinoma in Argentina. [2021]
U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. [2022]
Vismodegib (erivedge) for advanced Basal cell carcinoma. [2023]
Hepatotoxicity with Vismodegib: An MD Anderson Cancer Center and Research on Adverse Drug Events and Reports Project. [2018]
Vismodegib for periocular basal cell carcinoma: an international multicentre case series. [2021]
Vismodegib (ERIVEDGE) pregnancy prevention programme: assessment of risk awareness. [2022]
Vismodegib and the Hedgehog Pathway Inhibitors: A Historical Perspective to Current Clinical Application. [2018]
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