Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00079612
First received: March 9, 2004
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

The purpose of the study is to:

  • Find out if BAY 43-9006 prevents the growth of tumors
  • For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
  • Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
  • Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, 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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of progressions post randomization to placebo or sorafenib [ Time Frame: 12 weeks post randomization ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Until Progression occurs ]
  • Duration of objective tumor response [ Time Frame: Time from initial Response to documented Tumor Progression ]
  • Overall survival time [ Time Frame: At the End-of-Study visit ]

Enrollment: 350
Study Start Date: September 2002
Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
800mg daily (2x 400mg tabs)
Placebo Comparator: Arm 2 Drug: Placebo
2x 400mg tabs daily

  Eligibility

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

Inclusion Criteria:

  • Age > 18 years- Patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable
  • Patients with non-colorectal cancers are eligible and must be progressing at the time of the screening assessment and for whom no other treatment exists
  • Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria - Histological or cytological documentation of cancer- ECOG Performance status 0 or 1
  • Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function (assessed by the following laboratory requirements):
  • Hemoglobin >/= 9.0 g/dl - Absolute neutrophil count (ANC) >/=1,500/mm3
  • Platelet count = 100,000/µl3
  • Total bilirubin </=1.0 times the upper limit of normal unless due to Gilbert's
  • ALT and AST </= 2.5 x upper limit of normal. (For patients with hepatic involvement of their cancer, ALT and AST < 5.0 x upper limit of normal)
  • PT-INR/PTT < 1.5 x upper limit of normal. (Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.

In addition, these patients must be monitored with weekly coagulation assessments throughout the Run-in Period)- Serum creatinine < 1.5 x upper limit of normal

Exclusion Criteria:

  • Patients who meet the following criteria at the time of screening will be excluded:
  • Non small cell lung cancer, hepatocellular cancer, CML and AML
  • Serious cardiac arrhythmia
  • Congestive Heart Failure (NYHA Class 3 or 4)
  • Active of coronary artery disease or ischemia
  • Active acute infections that could be worsened by anticancer therapy or interfere with this study
  • Known HIV infection
  • Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
  • Patients currently receiving medication (steroid or anticonvulsant therapy) for seizure disorder
  • History of organ allograft- Previous or concurrent cancer that is distinct from the cancer being evaluated in this study. Several situations are excluded, including cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial bladder tumors or any cancer definitively treated greater than 3 years
  • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to the first dose of study drug
  • Radiotherapy during the study or within 3 weeks prior to the first dose of study drug
  • Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of study drug
  • Biological response modifiers, such as G-CSF within 3 weeks prior to study entry
  • Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study
  • Investigational drug therapy outside of this trial during or within 4 weeks prior to the screening assessment
  • Any previous exposure to a Ras pathway inhibitor
  • Pregnant or breast feeding patients. Women of child bearing potential must have a negative pregnancy test. Adequate barrier contraception will be required for both male and female patients during the entire course of the trial
  • Substance abuse, medical or psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with the trial
  • Any condition that is unstable or could jeopardize the safety of the patient and/or their compliance in the study
  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: NCT00079612

Locations
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United Kingdom
London, Greater London, United Kingdom, SW3 6JJ
Glasgow, Strathclyde, United Kingdom, G11 6NT
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bayer
Onyx Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00079612     History of Changes
Obsolete Identifiers: NCT00044499
Other Study ID Numbers: 100391
Study First Received: March 9, 2004
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Renal Cell Cancer
RCC
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 August 21, 2014