1st-line Activity of Dovitinib and Correlation With Genetic Changes in RCC

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Clear Cell Renal Cell Carcinoma
Interventions
DRUG

Dovitinib

"Patients will be treated with dovitinib (500 mg orally, once daily 5 days on/2 days off) until disease progression, intolerability, patient refusal, death or study drug discontinuation for any other reason. Dovitinib should be ingested at least 1 hour prior to a meal or at least 2 hours following a meal at approximately the same time each day.~If patients cannot tolerate the protocol-specified dosing schedule, dose reductions or treatment interruptions are permitted. When necessary, dovitinib may be reduced to 400 mg for 5 days on/2 days off. If an additional dose reduction is required, dovitinib may be reduced to 300 mg dose 5 days on/2 days off. Once dose is reduced due to an adverse event, it cannot be re-escalated. Patients are allowed only 2 dose reductions."

Trial Locations (1)

1142

Auckland Hospital, Auckland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Auckland, New Zealand

OTHER

collaborator

IGENZ, Ltd., Auckland

UNKNOWN

collaborator

Novartis

INDUSTRY

lead

Auckland District Health Board

OTHER_GOV