Sorafenib in Relapsed High Grade Osteosarcoma

Osteosarcoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889057
• Other study ID #: HGosteo-BAY
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2009
• Last updated: March 26, 2013
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthItaly: AIFA (Agenzia Italiana del FArmaco) - Osservatorio per le Sperimentazioni Cliniche
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• sorafenib
400 mg bid until progression or inacceptable toxicity

Locations

Country	Name	City	State
Italy	Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna
Italy	I.R.C.C. - Unit of Medical Oncology	Candiolo	Torino
Italy	Istituto Nazionale Tumori - Unit of Medical Oncology	Milano
Italy	Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor assessment through radiologic evaluation.		every 8 weeks	No