Status:
COMPLETED
Sutent Rechallenge In mRCC Patients
Lead Sponsor:
Pfizer
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
Detailed Description
A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to es...
Eligibility Criteria
Inclusion
- Histologically documented metastatic RCC containing predominantly clear cell component.
- Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
- At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
- At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
- Life expectancy of at least 3 months.
Exclusion
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01827254
Start Date
July 1 2013
End Date
April 1 2014
Last Update
April 30 2015
Active Locations (18)
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1
CHU de la Timone
Marseille, Cedex 5, France, 13335
2
Hopital albert Michalon
Grenoble, Cedex 9, France, 38043
3
Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, France, France, 42271
4
Centre Paul Papin
Angers, France, 49100