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Sutent Rechallenge In mRCC Patients

Last updated on November 21, 2019

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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Descriptive Information
Brief TitleSutent Rechallenge In mRCC Patients
Official TitleEtude Resume (Retraitement Sunitinib Rein Metastatique)
Brief SummaryRetrospective 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 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).

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationmRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
ConditionMetastatic Renal Cell Carcinoma
InterventionOther: 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
Study Groups/CohortsNon-Interventional Study
Intervention: Other: sunitinib: observational study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: April 28, 2015)
61
Original Estimated Enrollment
 (submitted: April 4, 2013)
60
Actual Study Completion DateApril 2014
Actual Primary Completion DateApril 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 .
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01827254
Other Study ID NumbersA6181211
ETUDE RESUME ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2015

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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