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Trial record 1 of 1 for:    NCT01827254
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Sutent Rechallenge In mRCC Patients (RESUME)

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ClinicalTrials.gov Identifier: NCT01827254
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date March 25, 2013
First Posted Date April 9, 2013
Results First Submitted Date April 8, 2015
Results First Posted Date April 30, 2015
Last Update Posted Date April 30, 2015
Study Start Date July 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2015)
  • Progression Free Survival With Sunitinib as First Line of Therapy [ Time Frame: From start of treatment up to 66.6 months ]
    The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
  • Progression Free Survival for Re-challenge With Sunitinib [ Time Frame: From start of treatment up to 52.2 months ]
    The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.
  • Progression Free Survival: Second Line of Treatment [ Time Frame: From start of treatment up to 22.9 months ]
    The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
  • Progression Free Survival: Third Line Treatment [ Time Frame: From start of treatment up to 23.7 months ]
    The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).
Original Primary Outcome Measures
 (submitted: April 4, 2013)
Progression-Free Survival (PFS) [ Time Frame: Baseline up to 6 months ]
Change History Complete list of historical versions of study NCT01827254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 28, 2015)
  • Overall Survival [ Time Frame: Baseline up to death or end of study (up to 98.0 months) ]
    Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12.
  • Percentage of Participants With Objective Response [ Time Frame: Baseline up to 98.0 months ]
    Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.
Original Secondary Outcome Measures
 (submitted: April 4, 2013)
Percentage of Participants With Objective Response [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2015)
Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 24 months ]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sutent Rechallenge In mRCC Patients
Official Title Etude Resume (Retraitement Sunitinib Rein Metastatique)
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population mRCC patients treated with sunitinib in first line and rechallenged with sunitinib in 3rd and 4th line
Condition Metastatic Renal Cell Carcinoma
Intervention 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
Study Groups/Cohorts Non-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 Status Completed
Actual Enrollment
 (submitted: April 28, 2015)
61
Original Estimated Enrollment
 (submitted: April 4, 2013)
60
Actual Study Completion Date April 2014
Actual Primary Completion Date April 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01827254
Other Study ID Numbers A6181211
ETUDE RESUME ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015