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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

Phase 3
18 Years
Not Enrolling
Sarcoma, Soft Tissue

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Trial Information

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 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS was defined as the time interval between the date of randomization and the earliest date of either disease progression or death due to any cause. The diagnosis of progression was based on tumor measurements, according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria, by independent radiologic assessment. The Kaplan-Meier method was used for PFS estimates.

Outcome Time Frame:

From the date of randomization until the date of the first documented radiological progression or date of death from any cause, whichever came first (assessed for an average of 10 months)

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

December 2012

Related Keywords:

  • Sarcoma, Soft Tissue
  • metastatic soft-tissue sarcoma
  • pazopanib
  • Soft Tissue Sarcoma
  • placebo
  • Sarcoma