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

Phase 1

• Conditions: Soft Tissue Sarcoma; MedDRA version: 9.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomas

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-16
• Last Update Posted: 21 August 2017

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

Exclusion Criterion 3 revised (note - section re-organized)
•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.