Trials / Completed
CompletedNCT00684645
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 186 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.
Detailed description
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SUTENT | SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity. |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2008-05-26
- Last updated
- 2012-08-21
- Results posted
- 2012-08-21
Locations
20 sites across 1 country: Czechia
Source: ClinicalTrials.gov record NCT00684645. Inclusion in this directory is not an endorsement.