Carcinoma, Renal Cell
Conditions
Keywords
BAY 43-9006, Phase II, Renal cell carcinoma, Response rate
Brief summary
To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.
Interventions
BAY 43-9006 400mg b.i.d. Treatment will continue until progression of underlying disease, unacceptable toxicity whose causal relationship to the study drug cannot be ruled out and which requires discontinuation of the drug, or consent withdrawal.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rate | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma | 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. |
| Time to death | At the time of death |
| Time to progression | 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. |
| Overall disease control rate | 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. |
| FACT-G and FKSI | Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter. |
| Overall response duration and time to objective response | 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. |
Countries
Japan
Outcome results
None listed