Trials / Completed
CompletedNCT00496301
Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC
Phase II Clinical Trial, Non-Randomized, Multicentre, on the Combination of Gemcitabine, Capecitabine and Sorafenib (Bay 43-9006) in Treatment of Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (RCC)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Spanish Oncology Genito-Urinary Group · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Main Objective: To evaluate progression-free survival in patients with unresectable renal cell carcinoma (RCC) treated with a combination of gemcitabine, capecitabine, and sorafenib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gemcitabine, Capecitabine and Sorafenib (6 cycles) | Gemcitabine: 1000 mg/m2 i.v. days 1 and 8. Capecitabine: 650 mg/m2 i.v. day 1 to 14. (change to 500mg/m2 after amendment nº2 (dated on 10/10/2007) Sorafenib:400 mg/12h v.o. day 1 to 21 |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2008-04-01
- Completion
- 2008-12-01
- First posted
- 2007-07-04
- Last updated
- 2009-01-14
Locations
10 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00496301. Inclusion in this directory is not an endorsement.