BAY 43-9006 Phase II Study for Renal Cell Carcinoma - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00661375

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Time to death [ Time Frame: At the time of death ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
FACT-G and FKSI [ Time Frame: Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter. ] [ Designated as safety issue: No ]

Enrollment:	108
Study Start Date:	November 2004
Study Completion Date:	January 2006

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY43-9006) 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661375

Show 51 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11515
Study First Received:	April 4, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00661375 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:

BAY 43-9006
Phase II
Renal cell carcinoma
Response rate

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Carcinoma
Renal Cancer

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009