Study of BAY 43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer - Full Text View

Purpose

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY 43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Condition	Intervention	Phase
Cancer Carcinoma, Renal Cell	Drug: Nexavar (Sorafenib, BAY 43-9006) Drug: Placebo	Phase III

MedlinePlus related topics:

Cancer

Drug Information available for:

Sorafenib Sorafenib tosylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III Randomized Study of BAY 43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

Further study details as provided by Bayer:

Primary Outcome Measures:

Overall survival [ Time Frame: 31 Mar 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate Progression-free Survival (PFS) [ Time Frame: 31Dec2005 ] [ Designated as safety issue: No ]
To evaluate the best overall response rate [ Time Frame: 31Mar2007 ] [ Designated as safety issue: No ]
To assess changes in the patient's health-related [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
To determine overall response duration and time to objective response [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
To determine overall disease control rate [ Time Frame: 30Sep2007 ] [ Designated as safety issue: No ]
Safety [ Time Frame: 30Sep2007 ] [ Designated as safety issue: Yes ]

Enrollment:	905
Study Start Date:	November 2003
Estimated Study Completion Date:	December 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Drug: Placebo Placebo
Arm 1: Experimental	Drug: Nexavar (Sorafenib, BAY 43-9006) Multi Kinase Inhibitor

Eligibility

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

Criteria

Inclusion Criteria:

Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
Patients who have adequate coagulation, liver and kidney functions

Exclusion Criteria:

Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Patients with a history or presence of metastatic brain or meningeal tumors
Patients with seizure disorder requiring medication (such as anti-epileptics) History of organ allograft or bone marrow transplant of stem cell rescue
Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
Patients who have three or more of the following:
1. ECOG performance status greater than or equal to 2,
2. Abnormally high lactate dehydrogenase,
3. Abnormally high serum hemoglobin,
4. Abnormally high corrected serum calcium,
5. Absence of prior nephrectomy

Excluded therapies and medications, previous and concomitant:

Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
Significant surgery with 4 weeks of start of study
Investigational drug therapy during or within 30 days
Concomitant treatment with rifampin or St. John's Wort
Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073307

Show 123 Study Locations

Sponsors and Collaborators

Bayer

ONYX Pharmaceuticals

Investigators


Study Chair:	Study Chair, M.D.	Cleveland Clinic Cancer Center, Cleveland, Ohio, USA

Study Chair:	Study Chair, M.D.	Institut Gustave Roussy (IGR), Villejuif, France

More Information

#PL#N. Engl. J. Med. 356 (2) 125- 134 (2007) ISSN:0028-4793 This link exits the ClinicalTrials.gov site

#PL#PubMed. This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11213
First Received:	November 19, 2003
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00073307
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Bayer:

Renal Cell Cancer (RCC)

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Sorafenib

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Bayer ONYX Pharmaceuticals
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00073307