RAGNAR - 42756493CAN2002
Research type
Research Study
Full title
A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations
IRAS ID
271121
Contact name
Ruth Plummer
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2019-002113-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
This is a Phase 2, open-label study of efficacy and safety of erdafitinib in participants with advanced solid tumours (cancers such as sarcomas, carcinomas, and lymphomas that have advanced to a stage where they are unlikely to be cured or controlled by treatment) and fibroblast growth factor receptor (FGFR) gene alterations (receptors that bind to members of the fibroblast growth factor family of proteins). Urothelial tumours are excluded from this study as there are current studies already investigating the effects of the study medication in participants with those cancers.
Patients with solid tumours with a significant frequency of FGFR alterations have a dismal prognosis in advanced disease and limited efficacy with standard of care options in the recurrent, metastatic setting, especially for second-line therapy or beyond. Erdafitinib is a drug that targets FGFRs that has shown benefit in cancer patients with certain genetic changes affecting this group of proteins.
This study will enroll participants into 2 cohorts: the Broad Panel Cohort will enroll patients with target FGFR mutations, as defined in the study protocol, or any gene fusion, and the Exploratory Cohort will enroll patients with FGFR mutations not captured in the Broad Panel Cohort. The study consists of a Screening Phase (including molecular pre-screening), a Treatment Phase and a Follow-up Phase. The Treatment Phase will continue until disease progression, intolerable toxicity, withdrawal of consent, or decision by the investigator to discontinue treatment. The post-treatment Follow-up Phase will extend from the End-of-Treatment Visit until the participant has died, withdraws consent, is lost to follow-up, or the study ends, whichever comes first. It is anticipated that most participants will be in the study for around 2 years.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0126
Date of REC Opinion
31 Oct 2019
REC opinion
Further Information Favourable Opinion