Last updated: 11/04/2018 13:33:06
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior TherapyPALETTE
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Progression-free Survival (PFS)
Timeframe: 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)
Secondary outcomes:
Overall Survival (OS)
Timeframe: From the date of randomization until 215 deaths (assessed for an average of 12 months)
Number of participants in the indicated categories for overall response assessed by an Independent Radiologist and the Investigator
Timeframe: From the start of treatment until disease progression (assessed for an average of 10 months)
Time to response assessed by an Independent Radiologist and the Investigator
Timeframe: From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
Duration of response assessed by the Independent Radiologist and the Investigator
Timeframe: From the date of randomization until the date of the first documented evidence of CR or PR (assessed for an average of 10 months)
PFS in the indicated histology subgroups of Soft Tissue Sarcoma (STS)
Timeframe: 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)
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: 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
Change from baseline in heart rate
Timeframe: 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
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
Timeframe: From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
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
Timeframe: From baseline (Day 1) until study drug discontinuation or end of treatment (assessed for an average of 20 weeks)
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)
Timeframe: 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)
Interventions:
Drug: PAZOPANIB
Drug: Placebo
Enrollment:
369
Observational study model:
Not applicable
Primary completion date:
2010-22-11
Time perspective:
Not applicable
Clinical publications:
van Der Graaf WTA, Blay JY, Chawla SP, Kim D, Nguyen BB, Casali PG. Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesnen A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji R, Demetri G, AP Dei Tos, Hohenberger P. Pazopanib in metastatic soft tissue sarcoma (PALETTE, EORTC 62072): a randomized, double-blind, placebo controlled phase 3 trial.. Lancet. 2012;379(9829):1879-86.
Frezza A, Benson C, Judson I, Litière S, Marreaud S, Sleijfer S, Blay JY, Dewji R, Fisher C, van der Graaf W, Hayward L. Pazopanib in advanced desmoplastic small round cell tumours: a multi-institutional experience. Clin Sarcoma Res. 2014;4:7.
Kasper B, Sleijfer S, Litière S, et al. 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;25(3):719-24.
van Der Graaf WTA, Blay JY, Chawla SP, et al. Pazopanib in metastatic soft tissue sarcoma (PALETTE, EORTC 62072): a randomized, double-blind, placebo controlled phase 3 trial. Lancet. 2012;379(9829):1879-86.
Medical condition
Sarcoma, Soft tissue
Product
pazopanib
Collaborators
Not applicable
Study date(s)
October 2008 to November 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion/Exclusion Criteria:
- High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
Inclusion and exclusion criteria
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 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.
Trial location(s)
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Rozzano (MI), Lombardia, Italy, 20089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Saarow, Brandenburg, Germany, 15526
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goyang-si, Gyeonggi-do, South Korea, 410-769
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90403
Status
Study Complete
Location
GSK Investigational Site
Clevand, Ohio, United States, 44106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M20 4BX
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60657
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35243
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Woolloongabba, Queensland, Australia, 4102
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Kurralta Park, South Australia, Australia, 5037
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2010-22-11
Actual study completion date
2012-28-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website