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. - PALETTE
- Conditions
- soft tissue sarcomaMedDRA version: 9.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomas
- Registration Number
- EUCTR2008-001307-33-IT
- Lead Sponsor
- GlaxoSmithkline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 255
1. High or intermediate grade of Soft Tissue Sarcoma. Eligible tumour types are listed in the protocol 2. The objective progression of disease will be assessed by investigator according to RECIST within 6months prior to study enrolment or within 12months prior to study enrolment, if the only prior systemic therapy of the sarcoma was given in the adjuvant or pre-operative setting 3. Metastatic disease 4. Measurable disease 5. Patients may have received a maximum of 4 prior lines of systemic therapies for advanced disease. (neo-)adjuvant/maintenance treatments are not counted for this criterion. 6. Last dose of prior therapy can be given up to 14days prior to starting the study; all ongoing toxicity from prior anthracycline therapy are grade 1 or resolved 7. Patients whose disease has progressed on or after anthracycline therapy 8. Patients whose disease has progressed on or after available standard chemotherapies at the treating institution except if medically contraindicated or refused by the patient 9. Patients may have been intolerant or progressed on or after their last therapy 10. WHO PS 1 11. Normal bone marrow, liver, renal and cardiac function 12. Contraception 13. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
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
1. No known history of leptomeningeal or brain metastases 2. No patient with poorly controlled hypertension (at baseline BP>150/90 is defined as poorly controlled) 3. No history of clinically significant gastrointestinal abnormalities 4. Exclude patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6months, patients who have suffered a deep vein thrombosis (DVT) or a pulmonay embolism in the past 6months. Nb. patients with recent DVT who haveb een treated with therapeutic anti-coagulating agents and remained stable for at least 6weeks are eligible. 5. No evidence of active bleeding or bleeding diathesis 6. No hemoptysis within 6weeks of first dose of study drug. Nb. any patient with a prior history of hemoptysis associated with metastatic disease must have a bronchoscopy to rule out endobronchial lesion would be excluded from study. 7. No prior major surgery or trauma within 28days prior to treatment start 8. Restriction for concomitant medications (see Chapter 5.8) 9. Patients who have been previously treated with inhibitors of angiogenesis and/or VEGF or VEGFR-targeting agents. mTOR inhibitors are not considered as inhibitors of angiogenesis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal objective of the trial is to investigate whether treatment with pazopanib improves the outcome of patients with metastatic soft tissue sarcoma, when compared with placebo.;Secondary Objective: not applicable;Primary end point(s): The primary end-point is overall progression free survival. Progression will be defined according to the ``RECIST``. Secondary end-points include Overall survival Adverse events, that will be graded according to the ``Common Terminology Criteria for Adverse events``, (CTCAE, version 3.0, electronically available on the NCI web site).
- Secondary Outcome Measures
Name Time Method