Sorafenib in Relapsed High Grade Osteosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889057
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group

Brief Summary:
Aim of this exploratory phase II study is to assess the clinical activity of sorafenib as single agent, in terms of percentage of patients with high grade advanced osteosarcoma free from progression following 4 months of therapy

Condition or disease Intervention/treatment Phase
Osteosarcoma Drug: sorafenib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With Sorafenib (BAY 43-9006) in Patients Affected by Relapsed High-grade Osteosarcoma.
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: sorafenib Drug: sorafenib
400 mg bid until progression or inacceptable toxicity

Primary Outcome Measures :
  1. Tumor assessment through radiologic evaluation. [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease.
  • measurable disease as defined by having at least one lesion that can be accurately measured by means of CT or MRI.
  • ECOG PS of 0, 1 and an estimated life expectancy of at least 3 months. ECOG P.S. 2 is acceptable provided that it depends solely on orthopedic problems
  • Age ≥15 years.
  • Adequate bone marrow, liver and renal function
  • Written informed consent

Exclusion Criteria:

  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  • Coexisting malignancies, except for basal or epithelial cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥3 years.
  • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
  • History of HIV infection or chronic hepatitis B or C.
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic 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 with seizure disorders requiring medication (such as steroids or anti-epileptics)
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • Patients unable to swallow oral medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889057

I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
Istituto Nazionale Tumori - Unit of Medical Oncology
Milano, Italy, 20133
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy, 10126
Sponsors and Collaborators
Italian Sarcoma Group
Study Chair: Massimo Aglietta, MD I.R.C.C - FPO Candiolo
Principal Investigator: Giovanni Grignani, MD I.R.C.C. - FPO Candiolo

Responsible Party: Prof. Massimo Aglietta, Professor, Italian Sarcoma Group Identifier: NCT00889057     History of Changes
Other Study ID Numbers: HGosteo-BAY
EudraCT Number: 2007-004396-19
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Prof. Massimo Aglietta, Italian Sarcoma Group:
target therapy

Additional relevant MeSH terms:
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs