CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 564 enrolled
Drug / intervention
Dovitinib +1 moredrug
Likely dose
Dovitinib 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01223027
NCT01223027Phase 3Completed
CompareCT.gov

An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

Novartis Pharmaceuticals·interventional·Posted Oct 18, 2010·Updated Dec 7, 2015

In Brief

A Phase 3 clinical trial evaluating Dovitinib and Sorafenib for Metastatic Renal Cell Carcinoma. Completed, enrolled 564 participants across 199 sites in 27 countries.

Detailed Summary

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Renal Cell Carcinoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2010
Enrollment StartMar 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.7 years ago

Interventions

Dovitinibdrug

Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.

Sorafenibdrug

Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.