N/A
N=61
Sutent Rechallenge In mRCC Patients
Metastatic Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01827254 ↗Enrolled (actual)
61
Serious AEs
40.4%
Results posted
Apr 2015
Primary outcome: Primary: Progression Free Survival With Sunitinib as First Line of Therapy — 18.4 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- sunitinib: observational study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival With Sunitinib as First Line of Therapy |
18.4 | — |
| PRIMARY Progression Free Survival for Re-challenge With Sunitinib |
7.9 | — |
| PRIMARY Progression Free Survival: Second Line of Treatment |
5.0; 6.2 | — |
| PRIMARY Progression Free Survival: Third Line Treatment |
4.8; 10.8 | — |
| SECONDARY Overall Survival |
55.9 | — |
| SECONDARY Percentage of Participants With Objective Response |
53.8; 15.4; 75.0 | — |
Summary
Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.
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 .
Data sourced from ClinicalTrials.gov (NCT01827254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.