drugset

drugset / Trial / NCT01215136

First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma

NCT01215136 ↗

Phase 2 Terminated 36 enrolled Matthew Galsky Hoosier Cancer Research Network · collab Novartis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to explore the activity and safety of everolimus +/- paclitaxel as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma.

Timeline

Start: 2010-12
Primary completion: 2017-04-24
Completion: 2018-04-24

Publications

Jun T, Hahn NM, Sonpavde G, Albany C, MacVicar GR, Hauke R, Fleming M, Gourdin T, Jana B, Oh WK, Taik P, Wang H, Varadarajan AR, Uzilov A, Galsky MD. Phase II Clinical and Translational Study of Everolimus +/- Paclitaxel as First-Line Therapy in Cisplatin-Ineligible Advanced Urothelial Carcinoma. Oncologist. 2022 Jun 8;27(6):432-e452. doi: 10.1093/oncolo/oyab075.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Everolimus	Small molecule	10 mg	Oral
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications