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

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ClinicalTrials.gov Identifier: NCT00079612
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE March 9, 2004
First Posted Date  ICMJE March 11, 2004
Last Update Posted Date December 19, 2014
Study Start Date  ICMJE September 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Number of progressions post randomization to placebo or sorafenib [ Time Frame: 12 weeks post randomization ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00079612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
Official Title  ICMJE Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE
  • Drug: Sorafenib (Nexavar, BAY43-9006)
    800mg daily (2x 400mg tabs)
  • Drug: Placebo
    2x 400mg tabs daily
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2014)
501
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079612
Other Study ID Numbers  ICMJE 100391
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Amgen
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP