check_circleStudy Completed

Carcinoma, Renal Cell

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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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 - ALT and AST - 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
  • - 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

Trial summary

Enrollment Goal
501
Trial Dates
September 2002 - January 2007
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
University of ChicagoChicago, 60637, United States
Terminated
Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
Institute for Drug DevelopmentSan Antonio, 78229, United States
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom

Primary Outcome

  • Number of progressions post randomization to placebo or sorafenib
    date_rangeTime Frame:
    12 weeks post randomization
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    Safety Issue:
    None

Secondary Outcome

  • Time to progression
    date_rangeTime Frame:
    Until Progression occurs
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    Safety Issue:
    None
  • Duration of objective tumor response
    date_rangeTime Frame:
    Time from initial Response to documented Tumor Progression
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    Safety Issue:
    None
  • Overall survival time
    date_rangeTime Frame:
    At the End-of-Study visit
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    Safety Issue:
    None

Trial design

Randomized Discontinuation Study of BAY 43-9006 in patients with Advanced Refractory Cancer.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2