Klinische Studie
Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)(PROOF 302)Phase 3, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations
Krankheitsentität(en)
Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien- Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy
- If have had adverse events (AEs) associated with prior surgery or neoadjuvant chemotherapy, they havestabilized or resolved to Grade ≤2 before randomization
- Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- If a woman of childbearing potential (WOCBP), must have a negative pregnancy test within 7 days of thefirst dose of study drug
Wesentliche Ausschlusskriterien-1.Presence of positive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy.
2.Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for NMIBC within the previous30 days.
3.Are currently receiving or are planning to receive during participation in this study, treatment with agentsthat are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorusand/or calcium concentration. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs,including carbamazepine, phenytoin, phenobarbital, and primidone. See Appendix 2 (Section 17.2).
•Prior neoadjuvant chemotherapy or immunotherapy is allowed if inclusion criterion #3 is met. Priorchemotherapy must have been completed within a period of time that is greater than the cycle lengthused for that treatment before the first dose of study drug. Subjects who received biologic therapyshould have completed therapy with a period that is ≥ 5 half-lives before the first dose of study drug.
4.Are planning to receive other systemic therapies intended to treat invasive urothelial carcinoma while on thisstudy.
5.Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) orselective FGFR inhibitor.
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de