Sorafenib in Relapsed High Grade Osteosarcoma
This study has been completed.
Sponsor:
Italian Sarcoma Group
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013