Sorafenib in Relapsed High Grade Osteosarcoma
This study has been completed.
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group
First received: April 27, 2009
Last updated: March 26, 2013
Last verified: March 2013
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
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Tumor assessment through radiologic evaluation. [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
400 mg bid until progression or inacceptable toxicity
|Ages Eligible for Study:
||15 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
Italian Sarcoma Group
||Massimo Aglietta, MD
||I.R.C.C - FPO Candiolo
||Giovanni Grignani, MD
||I.R.C.C. - FPO Candiolo
No publications provided
||Prof. Massimo Aglietta, Professor, Italian Sarcoma Group
History of Changes
|Other Study ID Numbers:
||HGosteo-BAY, EudraCT Number: 2007-004396-19
|Study First Received:
||April 27, 2009
||March 26, 2013
||Italy: Ministry of Health
Italy: AIFA (Agenzia Italiana del FArmaco) - Osservatorio per le Sperimentazioni Cliniche
Keywords provided by Italian Sarcoma Group:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action