FASE II PROSPECTIVE STUDY BAY-43-90006 IN ADVANCED, METASTATIC SOFT TISSUE SARCOMAS, AFTER ANTRACYCLINE-BASED THERAPY - ONC-2006-002

• Conditions: Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen; MedDRA version: 14.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-004437-15-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-13
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Histologically documented, progressive, advanced or metastatic sarcoma after adjuvant and/or first line antracycline-based regimen; ? At least one unidimensional target lesion (RECIST criteria); ? Age ≥ 18 years; ? Eastern Cooperative Oncology Group (ECOG) performance status  2; ? Life expectancy ≥ 12 weeks; ? The following laboratory parameters: ? Absolute neutrophyl count (ANC) > 1,5 x 109/L ? Platelet Count > 100X 109/L ? Serum Creatinine < 1,5 x the upper limit of normal ? Serum bilirubin < 1,5 mg/dL ? Alkaline phosphatase, alanine transaminase (ALT) and aspartate transaminase(AST) < 2,5 x the upper limit of normal; in case of hepatic metastases < 5 x the upper limit of normal.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Major surgery within 4 weeks of study entry; radiotherapy within 3 weeks of study entry; ? Previous or concurrent cancer that is distinct in primary site or histology from STS, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted; ? Renal failure requiring hemo- or peritoneal dialysis; ? History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (CAD); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted; ? Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0); ? Known history of human immunodeficiency virus (HIV) infection; ? Known Central Nervous System tumors including metastatic brain disease; ? Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry; ? History of organ allograft; ? Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results; ? Known or suspected allergy to the investigational agent or any agent given in association with this trial; ? Patients unable to swallow oral medications. ? Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified