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Adult Trials: 18+ Years
- 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.
- Patient who didn't receive Sunitinib in first line.
- Patient who received less than one line of treatment .
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| 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 | 61 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2015 | |||