Trial Information
Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma
Inclusion Criteria:
- Patients who suffer from unresectable and/or metastatic, measurable RCC
histologically or cytologically documented.
- Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor
containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma,
or chromophobe oncocytic tumors, are excluded from study participation.
Exclusion Criteria:
- More than three regimens of previous treatment for RCC
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate
Outcome Time Frame:
Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
11515
NCT ID:
NCT00661375
Start Date:
November 2004
Completion Date:
January 2006
Related Keywords:
- Carcinoma, Renal Cell
- BAY 43-9006
- Phase II
- Renal cell carcinoma
- Response rate
- Carcinoma
- Carcinoma, Renal Cell