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Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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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

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