NCT00661375 - BAY43-9006 Phase II Study for Renal Cell Carcinoma | Crick | Crick

BAY43-9006 Phase II Study for Renal Cell Carcinoma

Phase 2CompletedNCT00661375

Bayer131 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Carcinoma, Renal Cell

Interventions

Nexavar (Sorafenib, BAY43-9006)DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (51)

Outcomes

Primary Outcomes

Tumor response rate

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.

Secondary Outcomes

Time to progression

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.

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

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.

Time to death

Time frame: At the time of death

Overall response duration and time to objective response

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.

Overall disease control rate

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.

FACT-G and FKSI

Time frame: Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.

Data from ClinicalTrials.gov

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