Sorafenib in Relapsed High Grade Osteosarcoma

March 26, 2013 updated by: Prof. Massimo Aglietta, Italian Sarcoma Group

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Italy
      • Bologna, Italy, 40136
        • Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
      • Milano, Italy, 20133
        • Istituto Nazionale Tumori - Unit of Medical Oncology
      • Torino, Italy, 10126
        • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
    • Torino
      • Candiolo, Torino, Italy, 10060
        • I.R.C.C. - Unit of Medical Oncology

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

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sorafenib
Drug: sorafenib
400 mg bid until progression or inacceptable toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor assessment through radiologic evaluation.
Time Frame: every 8 weeks
every 8 weeks

Collaborators and Investigators

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

Sponsor

Italian Sarcoma Group

Investigators

  • Study Chair: Massimo Aglietta, MD, I.R.C.C - FPO Candiolo
  • Principal Investigator: Giovanni Grignani, MD, I.R.C.C. - FPO Candiolo

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

January 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGosteo-BAY
  • EudraCT Number: 2007-004396-19

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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