Table of contents
- Clinical trials overview
- Who is being studied
- What the trials measure
- Trial structure and phase
- Where Vismodegib appears in the trial data
- Patient-focused view of these studies
Clinical trials overview
The trial data show Phase 2 studies that test targeted cancer treatments in people with advanced cancer.[1][2][3][4] These studies are designed to describe how well treatment works and how safe it is in patients whose tumors have specific molecular changes.[1][2][3]
Across the trials, the main idea is precision medicine, which means using tumor test results to help choose a treatment.[1][2][3][4] The studies also aim to improve access to commercially available targeted anti-cancer drugs for patients who may benefit from them.[1][2][3]
Who is being studied
The trial populations include people with advanced cancer, advanced solid tumor, advanced pancreatic cancer, and other advanced malignancies.[1][2][3][4] One study also includes patients with non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, and multiple myeloma.[2]
These trials focus on patients whose tumors have a genomic- or protein expression variant, which is a change in the tumor’s DNA or protein pattern that may help predict response to a drug.[1][2] In the pancreatic cancer study, patients are selected because they have actionable reimbursed druggable molecular alterations, meaning tumor changes that may guide treatment choice.[4]
What the trials measure
The main outcome in one study is the percentage of patients treated based on their molecular tumor profile, which shows how often tumor testing leads to treatment selection.[1] The same study also measures treatment-related grade 3 or higher and serious adverse events, which are severe medical problems that happen during treatment.[1]
Another study measures objective tumor response, disease control at 16 weeks, and treatment-related grade 3 or higher and serious adverse events.[2] Disease control is defined in the trial as stable disease at 16 weeks after treatment starts.[2]
The Finnish study measures disease control rate at 16 weeks, defined as complete response, partial response, or stable disease.[3] The pancreatic cancer study measures progression-free survival, which is the time before the cancer gets worse.[4]
Trial structure and phase
All four trials are interventional, which means the researchers actively give a treatment rather than only observing patients.[1][2][3][4] Each study is in Phase 2, a stage that usually looks at how well a treatment works and continues to monitor safety.[1][2][3][4]
The trial sizes vary widely, from 250 participants in the Finnish study to 6000 participants in the Norwegian study.[1][3] The pancreatic cancer study plans to include 1200 participants, and the DRUP trial plans to include 3000 participants.[2][4]
Where Vismodegib appears in the trial data
Vismodegib appears in the pancreatic cancer trial as one of the targeted drugs being studied for patients with specific molecular alterations.[4] In the source data, it is listed as VISMODEGIB and is given by mouth in that study.[4]
The other trials in the data list Erivedge, which is another name that appears in the trial records for a Vismodegib product.[1][2][3] In these studies, Vismodegib is part of a broader set of targeted cancer medicines used in precision medicine programs.[1][2][3][4]
Patient-focused view of these studies
For patients, these trials are mainly about whether a tumor’s molecular features can help match the right treatment to the right person.[1][2][3][4] The studies are not simple “one drug for all” trials; they are testing targeted treatment choices based on tumor testing.[1][2][3][4]
Important terms in these trials include stable disease, which means the cancer is not clearly growing, and partial response or complete response, which mean the cancer has shrunk or disappeared on scans or other checks.[2][3] The studies also track serious side effects so researchers can understand the balance between benefit and risk.[1][2]
