Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00753688
Registration number
NCT00753688
Ethics application status
Date submitted
12/09/2008
Date registered
16/09/2008
Date last updated
22/08/2013
Titles & IDs
Public title
Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
VEG110727
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PALETTE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Sarcoma, Soft Tissue
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Sarcoma (also see 'Bone') - soft tissue
Query!
Cancer
0
0
0
0
Query!
Bone
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - PAZOPANIB
Treatment: Drugs - Placebo
Placebo comparator: PLACEBO - matching placebo 800 mg once daily orally
Experimental: PAZOPANIB - 800 mg once daily orally
Treatment: Drugs: PAZOPANIB
800 mg once daily orally
Treatment: Drugs: Placebo
matching placebo 800 mg once daily orally
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
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)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS was defined as the time from the date of randomization to the date of death due to any cause. The length of this interval was calculated as the date of death minus the date of randomization plus 1 day. Participants who were alive at the time of analysis were censored at the date of last follow-up. The interim OS analysis was conducted when 215 (77 percent \[%\]) of the 279 required death events had occurred in the study. The Kaplan-Meier method was used for OS estimates.
Query!
Timepoint [1]
0
0
From the date of randomization until 215 deaths (assessed for an average of 12 months)
Query!
Secondary outcome [2]
0
0
Number of Participants in the Indicated Categories for Overall Response Assessed by an Independent Radiologist and the Investigator
Query!
Assessment method [2]
0
0
Overall response is defined as the number of participants who had a complete response (CR) or a partial response (PR). According to RECIST, Version 1.0: CR, disappearance of all lesions; PR, a \>=30% decrease in the sum of the longest dimensions (LD) of the target lesions (TLs) taking as a reference the baseline sum LD; Progressive disease (PD), a \>=20% increase in the sum of the LD of TLs, or the appearance of \>=1 new lesion; Stable Disease (SD), neither PR nor PD, persistence of \>=1 non-TL. Participants with no follow-up radiological disease assessment were categorized as not evaluable (NE).
Query!
Timepoint [2]
0
0
From the start of treatment until disease progression (assessed for an average of 10 months)
Query!
Secondary outcome [3]
0
0
Time to Response Assessed by an Independent Radiologist and the Investigator
Query!
Assessment method [3]
0
0
Time to response was defined as the time from the date of randomization until the date of first documented evidence of CR or PR (whichever status was recorded first). The Kaplan-Meier method was used for time to response estimates.
Query!
Timepoint [3]
0
0
From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
Query!
Secondary outcome [4]
0
0
Duration of Response Assessed by the Independent Radiologist and the Investigator
Query!
Assessment method [4]
0
0
Duration of response was defined as the time from the date of the first documented evidence of CR or PR until the date of either the first documented sign of PD or death due to any cause. Participants who neither died nor progressed were censored at the date of the last adequate radiologic assessment. The Kaplan-Meier method was used for duration of response estimates.
Query!
Timepoint [4]
0
0
From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
Query!
Secondary outcome [5]
0
0
PFS in the Indicated Histology Subgroups of Soft Tissue Sarcoma (STS)
Query!
Assessment method [5]
0
0
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. Participants were analyzed for PFS in histology subgroups of STS (as per the World Health Organization \[WHO\] classification, 2008): leiomyosarcoma (malignant cancer of smooth muscle), synovial sarcoma (cancer near the joints of the arm or leg), and other STS (without the tumor type of leiomyosarcoma or synovial sarcoma), based on independent review.The Kaplan-Meier method was used for PFS estimates.
Query!
Timepoint [5]
0
0
From the date of randomization until the date of the first documented progression or the date of death from any cause, whichever came first (assessed for an average of 10 months)
Query!
Secondary outcome [6]
0
0
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Query!
Assessment method [6]
0
0
Change from baseline in on-therapy SBP and DBP was calculated as the values at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.
Query!
Timepoint [6]
0
0
Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104
Query!
Secondary outcome [7]
0
0
Change From Baseline in Heart Rate
Query!
Assessment method [7]
0
0
Change from baseline in on-therapy heart rate was calculated as the value at the indicated time points (Day 8 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104) minus the value at baseline.
Query!
Timepoint [7]
0
0
Baseline, Day 8, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 88, 96, and 104
Query!
Secondary outcome [8]
0
0
Number of Participants With the Indicated Grade Shifts From Baseline Grade for Hemoglobin Level, Lymphocyte Count, White Blood Cell Count, Neutrophil Count, and Platelet Count
Query!
Assessment method [8]
0
0
Shifts in hematology values by grade were summarized based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE Version 3.0). Grade refers to the severity of the AE. The CTCAE Version 3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 (severe AE) and 4 (life-threatening or disabling AE) at any point in the study after baseline are reported.
Query!
Timepoint [8]
0
0
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
Query!
Secondary outcome [9]
0
0
Number of Participants With the Indicated Grade Shifts From Baseline Grade for Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Creatinine, Hyper/Hypoglycemia, Hyper/Hypokalemia, Hyper/Hyponatremia, and Total Bilirubin
Query!
Assessment method [9]
0
0
Shifts in clinical chemistry values by grade were summarized based on the NCI CTCAE Version 3.0. Participants with a missing baseline grade were assumed to have a baseline Grade of 0. Any increase in grade from baseline and shifts to Grade 3 and 4 at any point in the study after baseline are reported. alkaline phosphatase, ALKP; alanine aminotransferase, ALT; aspartate aminotransferase, AST. Hyper/hypoglycemia refers to high/low glucose; hyper/hypokalemia refers to high/low potassium; hyper/hyponatremia refers to high/low sodium.
Query!
Timepoint [9]
0
0
From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
Query!
Secondary outcome [10]
0
0
Number of Participants With the Indicated Absolute Percent Change From Baseline (BL) in Left Ventricular Ejection Fraction (LVEF) at Any Time Post-BL (Worst Case On-therapy)
Query!
Assessment method [10]
0
0
LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction and is used to determine cardiac function (based on the institutional lower limit of normal \[LLN\]). LVEF was assessed at BL, Week 12, and every second scheduled visit thereafter until study drug discontinuation and end of treatment or as clinically indicated by using multi-gated acquisition scan (MUGA) or echocardiogram (ECHO). Absolute change from BL was calculated as the on-study value minus the baseline value (LVEF is calculated as a percentage).
Query!
Timepoint [10]
0
0
Baseline (within 14 days of the first dose of study drug) and any time post-baseline until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
Query!
Eligibility
Key inclusion criteria
Inclusion/
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
369
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Randwick
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Woolloongabba
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Kurralta Park
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Hobart
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Box Hill
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [4]
0
0
7000 - Hobart
Query!
Recruitment postcode(s) [5]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [6]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Minnesota
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Ohio
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Brussels
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gent
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Liège
Query!
Country [12]
0
0
Denmark
Query!
State/province [12]
0
0
Herlev
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Bordeaux cedex
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Lille
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Lyon Cedex 08
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Marseille cedex 5
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Paris Cedex 5
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Saint-Priest en Jarez
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Vandoeuvre-Les-Nancy
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Villejuif
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Baden-Wuerttemberg
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Brandenburg
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Hessen
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Niedersachsen
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Nordrhein-Westfalen
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Sachsen
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Campania
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Lazio
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Lombardia
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Piemonte
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Umbria
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Aichi
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Chiba
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Fukuoka
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Hokkaido
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Mie
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Okayama
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Osaka
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Tokyo
Query!
Country [40]
0
0
Korea, Republic of
Query!
State/province [40]
0
0
Daegu
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Goyang-si, Gyeonggi-do
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Seoul
Query!
Country [43]
0
0
Netherlands
Query!
State/province [43]
0
0
Amsterdam
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Groningen
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Leiden
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Nijmegen
Query!
Country [47]
0
0
Netherlands
Query!
State/province [47]
0
0
Rotterdam
Query!
Country [48]
0
0
Spain
Query!
State/province [48]
0
0
Madrid
Query!
Country [49]
0
0
Spain
Query!
State/province [49]
0
0
Palma de Mallorca
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
Valencia
Query!
Country [51]
0
0
Sweden
Query!
State/province [51]
0
0
Göteborg
Query!
Country [52]
0
0
Sweden
Query!
State/province [52]
0
0
Linköping
Query!
Country [53]
0
0
Sweden
Query!
State/province [53]
0
0
Lund
Query!
Country [54]
0
0
Sweden
Query!
State/province [54]
0
0
Umeå
Query!
Country [55]
0
0
Sweden
Query!
State/province [55]
0
0
Uppsala
Query!
Country [56]
0
0
United Kingdom
Query!
State/province [56]
0
0
Lancashire
Query!
Country [57]
0
0
United Kingdom
Query!
State/province [57]
0
0
Glasgow
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
Leeds
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
London
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Nottingham
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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
Query!
Trial website
https://clinicaltrials.gov/study/NCT00753688
Query!
Trial related presentations / publications
van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schoffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012 May 19;379(9829):1879-86. doi: 10.1016/S0140-6736(12)60651-5. Epub 2012 May 16. Cesne AL, Bauer S, Demetri GD, Han G, Dezzani L, Ahmad Q, Blay JY, Judson I, Schoffski P, Aglietta M, Hohenberger P, Gelderblom H. Safety and efficacy of Pazopanib in advanced soft tissue sarcoma: PALETTE (EORTC 62072) subgroup analyses. BMC Cancer. 2019 Aug 13;19(1):794. doi: 10.1186/s12885-019-5988-3. Kawai A, Araki N, Hiraga H, Sugiura H, Matsumine A, Ozaki T, Ueda T, Ishii T, Esaki T, Machida M, Fukasawa N. A randomized, double-blind, placebo-controlled, Phase III study of pazopanib in patients with soft tissue sarcoma: results from the Japanese subgroup. Jpn J Clin Oncol. 2016 Mar;46(3):248-53. doi: 10.1093/jjco/hyv184. Epub 2016 Feb 10. Kasper B, Sleijfer S, Litiere S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00753688
Download to PDF