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Evaluate The Efficacy Of Sunitinib Rechallenge In mRCC Patients Treated With Sutent In First Line And Rechallenged In 3rd And 4th Line


N/A
18 Years
80 Years
Not Enrolling
Both
Metastatic Renal Cell Carcinoma

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Trial Information

Evaluate The Efficacy Of Sunitinib Rechallenge In mRCC Patients Treated With Sutent In First Line And Rechallenged In 3rd And 4th Line


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 estimate the effect of Sutent rechallenge.

The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition,
the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs.
rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar
test for overall response rate (ORR).


Inclusion Criteria:



- 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 Criteria:

- Patient who didn't receive Sunitinib in first line.

- Patient who received less than one line of treatment .

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

Baseline up to 6 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

France: French Data Protection Authority

Study ID:

A6181211

NCT ID:

NCT01827254

Start Date:

June 2013

Completion Date:

December 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • sutent rechallenge
  • Carcinoma
  • Carcinoma, Renal Cell

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