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

December 18, 2014 updated by: Bayer

Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

501

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G11 6NT
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sorafenib (Nexavar, BAY43-9006)
800mg daily (2x 400mg tabs)
Placebo Comparator: Arm 2
Drug: Placebo
2x 400mg tabs daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of progressions post randomization to placebo or sorafenib
Time Frame: 12 weeks post randomization
12 weeks post randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 9, 2004

First Submitted That Met QC Criteria

March 10, 2004

First Posted (Estimate)

March 11, 2004

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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