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Sutent Rechallenge In mRCC Patients

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
CHU de la Timone
Marseille, Cedex 5, 13335 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Patient who received less than one line of treatment .

NCT01827254
Pfizer
Completed
Sutent Rechallenge In mRCC Patients

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Sutent Rechallenge In mRCC Patients
Etude Resume (Retraitement Sunitinib Rein Metastatique)
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent 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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
Metastatic Renal Cell Carcinoma
Other: sunitinib: observational study
Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line
Other Name: sunitinib 50 mg 4/2
Non-Interventional Study
Intervention: Other: sunitinib: observational study
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
April 2014
April 2014   (Final data collection date for primary outcome measure)

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 .
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01827254
A6181211
ETUDE RESUME ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

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