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Hedgehog Pathway Inhibitor

Treatment (Vismodegib) for Solid Tumors

Phase 2
Waitlist Available
Led By Anne S Tsao
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

"This trial is testing how well a medication called GDC-0449 (vismodegib) works in treating patients with certain types of advanced or refractory cancers that have a specific genetic mutation

Who is the study for?
This trial is for patients with advanced or treatment-resistant solid tumors, lymphoma, or multiple myeloma that have specific genetic mutations (smoothened or patched 1). Participants should have a tumor amenable to biopsy and must not be receiving other cancer treatments.Check my eligibility
What is being tested?
The study is testing the effectiveness of Vismodegib, a drug that targets the hedgehog signaling pathway which may inhibit cancer growth. It includes procedures like biopsies and heart monitoring through echocardiography to assess its impact on various cancers.See study design
What are the potential side effects?
Vismodegib can cause side effects such as muscle cramps, hair loss, taste disturbances, weight loss, fatigue, nausea, diarrhea and constipation. Some patients might also experience joint aches or missed menstrual periods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
6-month progression-free survival (PFS) rate
Overall survival (OS)
Progression free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Vismodegib)Experimental Treatment5 Interventions
Patients receive vismodegib orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or nuclear study during screening, tumor biopsy on study and CT scan, MRI and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radionuclide Imaging
2004
Completed Phase 2
~50
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Echocardiography
2013
Completed Phase 4
~11670
Vismodegib
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,682 Previous Clinical Trials
40,928,656 Total Patients Enrolled
Anne S TsaoPrincipal InvestigatorECOG-ACRIN Cancer Research Group
6 Previous Clinical Trials
324 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently open for this research study?

"Information from clinicaltrials.gov indicates that recruitment for this specific trial is currently closed. Despite being initially posted on February 24, 2016 and last updated on April 9, 2024, no new participants are being sought. However, it is worth noting that there are a substantial number of other trials—4874 in total—that are actively enrolling patients at present."

Answered by AI

Has the medication Vismodegib received official approval from the Food and Drug Administration (FDA) for treatment?

"Our assessment at Power indicates a safety rating of 2 for the Vismodegib treatment in this Phase 2 trial. This suggests that while there is existing safety data, efficacy evidence remains unestablished."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
2016. "Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06357988.
~2 spots leftby Nov 2024
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