Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

A Randomized Double Blind Phase III Trial of Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy

A randomized double blind phase III trial of Pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

Inclusion/Exclusion Criteria:

• High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
• Metastatic and measurable disease (RECIST);
• Subjects can have received maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease. (Neo) adjuvant/maintenance treatments are not counted for this criterion;
• Last dose of prior therapy can be given upto 14 days prior to start of study if all ongoing toxicity from prior anticancer therapy are grade 1 or resolved (except alopecia).
• Must have failed anthracycline-based therapy and available standard chemotherapies at the treating institution except if medically contraindicated or refused by patient;
• No treatment with anti-angiogenesis inhibitors;
• Age > 18 years
• WHO PS 0-1;
• No leptomeningeal or brain metastases, normal bone marrow, liver, renal and cardiac functions;
• No prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast or the patient has been free of any other malignancies for > 3 years)
• Adequate bone marrow function; adequate blood clotting results; adequate hepatic and renal function;
• No poorly controlled hypertension;
• Clinically normal cardiac function;
• No clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
• No cerebrovascular accidents 1
• No transient ischemic attack, deep vein thrombosis or pulmonary embolism within past six months;
• No active bleeding or bleeding diathesis;
• No hemoptysis within six weeks of study drug;
• No major surgery or trauma within 28 days of therapy treatment;
• Concomitant medication restriction;
• No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
• Ability to swallow & retain oral medication
• Adequate contraception must be used;
• No Psychological familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.