Study of Efficacy and Safety of Sunitinib Given on an Individualized Schedule

PHASE2CompletedINTERVENTIONAL
Enrollment

117

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

Conditions
Clear Cell, Metastatic Renal Cell Carcinoma
Interventions
DRUG

Sunitinib

The starting dose will be 50 mg Sunitinib on the 28/14 schedule. In patients that develop ≥ grade-2 toxicity after 2 weeks, therapy will be held for 7 days or resolution before continuing therapy according to the 1st dose/schedule change. In patients that do not develop ≥ grade-2 toxicity, therapy will continue for 1-2 weeks or until ≥ grade-2 toxicity. In patients that develop \> grade-2 toxicity after less than 4 weeks, therapy will be held for 7 days or before continued according to the 1st dose/schedule change. Patients that do develop grade-2 toxicity (but no more) on the 50 mg 28/14 schedule, will remain on schedule but the time off therapy will be reduced to 7 days if toxicity has resolved after a 7-day break. Patients that develop ≤ grade-1 toxicity on the 50 mg 28/14 schedule, will be dose escalated according to protocol.

Trial Locations (13)

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 4E6

BC Cancer Agency - Vancouver, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

B3H 3A7

QEII Health Sciences Centre, Halifax

L8V 5C2

Juravinski Cancer Centre, Hamilton

K7L 2V7

Kingston General Hospital Research Institute, Kingston

N6A 4L6

London Health Sciences Centre, London

L1G 2B9

Durham Regional Cancer Centre, Oshawa

K1H 8L6

Ottawa Hospital Cancer Centre, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

H2W 1T8

Notre-Dame Hospital, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Sunnybrook Health Sciences Centre

OTHER

NCT01499121 - Study of Efficacy and Safety of Sunitinib Given on an Individualized Schedule | Biotech Hunter | Biotech Hunter