BAY43-9006 Phase II Study for Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00661375
First received: April 4, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma

Resource links provided by NLM:


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: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661375     History of Changes
Other Study ID Numbers: 11515
Study First Received: April 4, 2008
Last Updated: October 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAY 43-9006
Phase II
Renal cell carcinoma
Response rate

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Niacinamide
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014