Sorafenib in Relapsed High Grade Osteosarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT00889057
First received: April 27, 2009
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Osteosarcoma
Drug: sorafenib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Italian Sarcoma Group:

Primary Outcome Measures:
  • Tumor assessment through radiologic evaluation. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sorafenib Drug: sorafenib
400 mg bid until progression or inacceptable toxicity

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889057

Locations
Italy
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
Investigators
Study Chair: Massimo Aglietta, MD I.R.C.C - FPO Candiolo
Principal Investigator: Giovanni Grignani, MD I.R.C.C. - FPO Candiolo
  More Information

No publications provided

Responsible Party: Prof. Massimo Aglietta, Professor, Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT00889057     History of Changes
Other Study ID Numbers: HGosteo-BAY, EudraCT Number: 2007-004396-19
Study First Received: April 27, 2009
Last Updated: March 26, 2013
Health Authority: Italy: Ministry of Health
Italy: AIFA (Agenzia Italiana del FArmaco) - Osservatorio per le Sperimentazioni Cliniche

Keywords provided by Italian Sarcoma Group:
osteosarcoma
sorafenib
target therapy

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014