Trials / Completed
CompletedNCT01827254
Sutent Rechallenge In mRCC Patients
Etude Resume (Retraitement Sunitinib Rein Metastatique)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 61 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | sunitinib: observational study | Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-04-09
- Last updated
- 2015-04-30
- Results posted
- 2015-04-30
Locations
18 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01827254. Inclusion in this directory is not an endorsement.