Open-label phase II trial with a pan_FGFR Tyrosine Kinase Inhibitor
Research type
Research Study
Full title
A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations
IRAS ID
177346
Contact name
Syed Hussain
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-002408-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
ClinicalTrials.gov, NCT02365597
Duration of Study in the UK
3 years, 0 months, 18 days
Research summary
This research is an open label phase 2 trial to investigate the efficacy and the Safety of two different dose regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ 42756493 suplied in cycles of 28days in subjects with metastatic or surgically unresectable urothelial cancer with FGFR genomic alterations.
In total 165 patients will be enrolled in this study with a 1:1 randomization ratio to regimen 1 (10 mg of oral study drug once daily on Days 1 through 7 and Days 15 through 21) or regimen 2 (6 mg of oral study drug once daily on Days 1 through 28 of a 28-day cycle) treament and stratified according to ECOG performance status, hemoglobin level, FGFR alteration type, pretreatment status, and disease distribution.
The study comprises a Screening Phase (molecular screening and full study screening), a Treatment Phase, and a post-treatment Follow-up Phase. Subjects will be assessed on a regular basis for disease response according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) guidelinesThe end of study is defined as 12 months after last subject is enrolled or anytime the Sponsor terminates the study.
Treatment can be up-titrated or maintained (based on phosphate level measured) or modified or terminated (based on toxicity).
There are 2 planned interim analyses performed for safety, futility, and dose selection.
After 110th patients have been treated with at least one dose, the preferred dose regimen will be selected.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0431
Date of REC Opinion
23 Jun 2015
REC opinion
Further Information Favourable Opinion