Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: PAZOPANIB; Placebo
Intervention description: 800 mg once daily orally; matching placebo 800 mg once daily orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic soft-tissue sarcoma; pazopanib; Soft Tissue Sarcoma; placebo

Summary:

      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
    

Eligibility criteria:

        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.