WO42758_Evaluating safety and efficacy of targeted therapies in mCC
Research type
Research Study
Full title
A PHASE I/Ib GLOBAL, MULTICENTER, OPEN-LABEL UMBRELLA STUDY EVALUATING THE SAFETY AND EFFICACY OF TARGETED THERAPIES IN SUBPOPULATIONS OF PATIENTS WITH METASTATIC COLORECTAL CANCER (INTRINSIC)
IRAS ID
1003729
Contact name
Abigail Chui
Contact email
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2021-001207-33
Research summary
The WO42758 study is evaluating patients who have colon cancer that has spread (metastatic colorectal cancer; mCRC), who are intolerant to the standard of care anti-cancer treatment, or whose cancer has continued to grow despite receiving anti-cancer treatment. The purpose of this study is to investigate the effects, good or bad, of inavolisib with cetuximab or bevacizumab treatment combination on patients with mCRC.
We are investigating a new drug called inavolisib. Inavolisib blocks a signal that cancer cells commonly use to grow and multiply. This signal is called the PI3K pathway. Previous clinical study results support giving inavolisib to patients whose mCRC carries a mutation in the gene that controls the PI3K pathway. This gene is called PIK3CA.
Because inavolisib has been shown to be effective against cancer cells with PIK3CA mutations, only patients whose tumours have a PIK3CA gene mutation will receive inavolisib with bevacizumab. In addition, only patients whose tumours have no mutations in the KRAS and NRAS genes and no BRAFV600E mutation will receive inavolisib with cetuximab.
It is expected there will be 4-5 groups. Globally, the proposed number of patients is initially 15-20 patients per group then up to 40 patients in each group following a dose expansion phase. In the UK, there will be approximately 18 patients recruited at 6 sites. The planned recruitment period is up to 2 years.
This is an early clinical trial and the study drug has only been given to a small number of patients (180 patients as of 29-Sep-2020).
The study will last approximately 24 months with the current treatment groups.
The study is sponsored by F. Hoffman La Roche.
Research Summary; V1.0 27May2021
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0187
Date of REC Opinion
13 Jul 2021
REC opinion
Further Information Favourable Opinion