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Research Study for Patients With Metastatic Renal Cell Carcinoma

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00110344
First received: May 6, 2005
Last updated: June 4, 2009
Last verified: June 2009
History of Changes
  Purpose

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: Nexavar (Sorafenib, BAY43-9006)
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Best Overall Response Rate (complete and partial response rate) [ Time Frame: During study treatment or within 30 days after termination of active therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Last date of tumor assessment ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: Last day of tumor assessement ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: all visits ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: November 2005
Study Completion Date: June 2006
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)

Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days.

Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.

Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
Placebo Comparator: Arm 2 Drug: Placebo

Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days.

Cycle 2 and 3: see above (no placebo application)

  Eligibility

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

Inclusion Criteria:

  • Life expectancy of at least 12 weeks
  • Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed
  • Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
  • At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
  • Patients who have an ECOG performance status of 0 or 1

Exclusion Criteria:

  • History of bleeding diathesis or unexpected surgical bleeding
  • Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
  • Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
  • Known history of HIV infection
  • Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110344

Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02115-6084
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00110344     History of Changes
Other Study ID Numbers: 11547
Study First Received: May 6, 2005
Last Updated: June 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013