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 Sarcoma; MedDRA version: 15.0Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-001307-33-DE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-22
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Histological evidence of high or intermediate grade of STS. Eligible tumor types are listed in the protocol
• Confirmed disease progression by RECIST within the past 6 months prior to study enrolment. or within 12 months if only received prior systemic (neo)–adjuvant therapy
• Metastatic disease
• Measurable disease according to RECIST
• Patients may have received a maximum of 4 prior lines of systemic therapies for advanced disease of which no more than two lines should be combination regimens. (neo)adjuvant/maintenance treatments are not counted for this criterion
• Last dose of prior therapy can be given up to 14 days prior to starting the study; all ongoing toxicity from prior anti-cancer therapy are grade 1 (except alopecia) or have resolved.
• Patients whose disease has progressed on or after anthracycline based regimen
• Patients whose disease has progressed on or after available standard chemotherapies at the treating institution except if medically contraindicated or refused by the patient
• WHO PS 0-1
• adequate bone marrow, coagulation, liver and renal function
• Clinically normal cardiac function based on the institutional lower limit of normal (LVEF assessed by MUGA or ECHO) and normal 12 lead ECG (no prolongation of corrected QT interval (QTc) > 480 msecs) less than 14 days prior to treatment start and no history of any one or more of the cardiovascular conditions listed in the protocol within the past 6 months
• Contraception
• 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

Exclusion Criteria

• Previous treatment with inhibitors of angiogenesis and/or VEGF or VEGFR-targeting agents. mTOR inhibitors are not considered as inhibitors of as inhibitors of angiogenesis
• Known history of central nervous system metastases or leptomeningeal tumor spread
• Prior history of malignancies other than sarcoma (exception noted in the protocol)
• Ongoing toxicity from prior anti-cancer therapy > Grade 1 (except alopecia) and/or that is progressing in severity
• Concurrent anti-cancer therapy including: chemotherapy, immunotherapy, biologic therapy, investigational therapy, radiotherapy, targeted agents or hormonal therapy within 14 days or five half-lives of a drug prior to the first dose of study medication and until 15 days after the last dose of study medication
• Use of any investigational agent during study treatment and until 15 days after the last dose of study medication
• Poorly controlled hypertension defined at baseline as blood pressure (BP) >150/90
• Cerebrovascular accident at any time in the past, transient ischemic attack in the past 6 months, deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months; note: patients with recent DVT who have been treated with therapeutic anti-coagulating agents and remained stable for at least 6 weeks are eligible
• History of clinically significant gastrointestinal disorders
• Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
• Evidence of active bleeding or bleeding diathesis
• Hemoptysis within 6 weeks prior to first dose of study drug
• Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether treatment with pazopanib improves the outcome of patients with metastatic soft tissue sarcoma, when compared to placebo.;Secondary Objective: Not applicable;Primary end point(s): Overall Progression Free Survival. Progression will be defined according to RECIST.