A PHASE II STUDY OF BAY 43-9006 IN COMBINATION WITH WEEKLY GEMCITABINE FOR THE TREATMENT OF METASTATIC RCC EITHER UNSUITABLE FOR OR REFRACTORY TO PRIOR TREATMENT WITH CYTOKINES - TAGUSG6

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000231-95-IT

Enrollment

Registered

2006-06-22

Start date

2006-02-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

METASTATIC RENAL CANCER CELL MedDRA version: 8.1 Level: PT Classification code 10050018 Term: Renal cancer metastatic

Interventions

Trade Name: Nexavar Pharmaceutical Form: Tablet Current Sponsor code: Bay 43-9006 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: Gemzar*1g Polv e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent - Advanced, histologically confirmed, RCC - ECOG PS 0-2 - Age 18 years - UISS 3 cathegory see appendix or immunotherapy refractory disease indipendently of UISS cathegory . - Presence of measurable disease - Adequate blood counts WBC 3.000/ml; HB 10 gr/dl; Ptl 100.000/ml liver Transaminases 2N; bilirubin 2N and kidney creatinine 2 ng/ml function tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Brain metastasis - Comorbid conditions which could represent a contraindication to receive the drugs on study or to jeopardize patient compliance - Unstable diabetes; active coronary disease; active serious infections - Recent gastrointestinal bleeding

Design outcomes

Primary

Measure	Time frame
Main Objective: - To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.;Secondary Objective: - To evaluate progression-free survival, overall survival, response duration, time to response. - To evaluate the combined regimen with respect to change in QoL status. - To evaluate the possible predictive value of baseline phosho ERK pERK , VEGFr 2 and 3 in tumour cells and of VEGF serum levels in determining tumor response.;Primary end point(s): To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.	—

Measure

Time frame

Main Objective: - To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.;Secondary Objective: - To evaluate progression-free survival, overall survival, response duration, time to response. - To evaluate the combined regimen with respect to change in QoL status. - To evaluate the possible predictive value of baseline phosho ERK pERK , VEGFr 2 and 3 in tumour cells and of VEGF serum levels in determining tumor response.;Primary end point(s): To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026