Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior TherapyPALETTE
Trial overview
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)
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)
Participation criteria
- Inclusion/Exclusion Criteria:
- High or intermediate grade of soft tissue sarcoma; Low grade tumours allowed provided there is disease progression.
- 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)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.