Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
11 gennaio 2016 aggiornato da: GlaxoSmithKline
A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC).
Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo.
The study treatment will continue until patients experience disease progression, unacceptable toxicity or death.
Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival.
Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival.
Other objectives are overall response rate [complete response (CR) + partial response (PR)], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events.
Safety and efficacy assessments will be regularly performed on all patients.
An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
435
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Quilmes, Argentina, 1878
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Tucuman, Argentina, 4000
- GSK Investigational Site
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1405CUB
- GSK Investigational Site
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Córdova
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Cordoba, Córdova, Argentina, 5000
- GSK Investigational Site
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Córdoba, Córdova, Argentina, 5000
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000KZE
- GSK Investigational Site
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New South Wales
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St Leonards, New South Wales, Australia, 2065
- GSK Investigational Site
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Waratah, New South Wales, Australia, 2298
- GSK Investigational Site
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Tasmania
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Hobart, Tasmania, Australia, 7000
- GSK Investigational Site
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Victoria
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Heidelberg, Victoria, Australia, 3084
- GSK Investigational Site
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Wodonga, Victoria, Australia, 3690
- GSK Investigational Site
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Salzburg, Austria, A-5020
- GSK Investigational Site
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Vienna, Austria, A-1090
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Vienna, Austria, A-1100
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Vienna, Austria, 1130
- GSK Investigational Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasile, 30150-270
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasile, 90610 000
- GSK Investigational Site
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São Paulo
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Jaú, São Paulo, Brasile, 17210-120
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile, 7500921
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7591046
- GSK Investigational Site
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Valparaíso
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Viña del Mar, Valparaíso, Chile, 254-0364
- GSK Investigational Site
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Beijing, Cina, 100034
- GSK Investigational Site
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Beijing, Cina, 100853
- GSK Investigational Site
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Seoul, Corea, Repubblica di, 120-752
- GSK Investigational Site
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Seoul, Corea, Repubblica di, 110-744
- GSK Investigational Site
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songpa-gu, Seoul, Corea, Repubblica di, 138-736
- GSK Investigational Site
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Tallinn, Estonia, 11619
- GSK Investigational Site
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Tartu, Estonia, 51014
- GSK Investigational Site
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Chelyabinsk, Federazione Russa, 454087
- GSK Investigational Site
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Kazan, Federazione Russa, 420029
- GSK Investigational Site
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Moscow, Federazione Russa, 115 478
- GSK Investigational Site
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Moscow, Federazione Russa, 129 128
- GSK Investigational Site
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Moscow, Federazione Russa, 117 837
- GSK Investigational Site
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Omsk, Federazione Russa, 644013
- GSK Investigational Site
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Samara, Federazione Russa, 443066
- GSK Investigational Site
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St. Petersburg, Federazione Russa, 198255
- GSK Investigational Site
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Voronezh, Federazione Russa, 394062
- GSK Investigational Site
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Yaroslavl, Federazione Russa, 150054
- GSK Investigational Site
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Athens, Grecia, 115 22
- GSK Investigational Site
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Athens, Grecia, 115 28
- GSK Investigational Site
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Athens, Grecia, 115 26
- GSK Investigational Site
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Athens, Grecia, 185 37
- GSK Investigational Site
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Patra, Grecia, 26500
- GSK Investigational Site
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Thessaloniki, Grecia, 564 29
- GSK Investigational Site
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Tuen Mun, New Territories, Hong Kong
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Bangalore, India, 560029
- GSK Investigational Site
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Hyderabad, India, 500033
- GSK Investigational Site
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Mumbai, India, 400026
- GSK Investigational Site
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Pune, India, 411 004
- GSK Investigational Site
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Trivandrum, India, 695011
- GSK Investigational Site
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Galway, Irlanda
- GSK Investigational Site
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Tallaght, Dublin, Irlanda, 24
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Lazio
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Roma, Lazio, Italia, 00133
- GSK Investigational Site
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Roma, Lazio, Italia, 00152
- GSK Investigational Site
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Lombardia
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Casalpusterlengo (LO), Lombardia, Italia, 26841
- GSK Investigational Site
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Crema, Lombardia, Italia, 26013
- GSK Investigational Site
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Milano, Lombardia, Italia, 20132
- GSK Investigational Site
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Rozzano (MI), Lombardia, Italia, 20089
- GSK Investigational Site
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Piemonte
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Orbassano (TO), Piemonte, Italia, 10043
- GSK Investigational Site
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Riga, Lettonia, LV 1002
- GSK Investigational Site
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Kaunas, Lituania, LT-50009
- GSK Investigational Site
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Klaipeda, Lituania, LT-92228
- GSK Investigational Site
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Vilnius, Lituania, LT-08660
- GSK Investigational Site
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Mexico City, Messico, CP 14080
- GSK Investigational Site
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Jalisco
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Guadalajara, Jalisco, Messico, CP44280
- GSK Investigational Site
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Yucatán
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Merida, Yucatán, Messico, 97500
- GSK Investigational Site
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Christchurch, Nuova Zelanda, 8001
- GSK Investigational Site
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Newtown, Wellington, Nuova Zelanda, 6002
- GSK Investigational Site
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Palmerston North, Nuova Zelanda, 4414
- GSK Investigational Site
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Islamabad, Pakistan, 1590
- GSK Investigational Site
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Karachi, Pakistan, 74800
- GSK Investigational Site
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Lahore, Pakistan, 54600
- GSK Investigational Site
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Gdansk, Polonia, 80-210
- GSK Investigational Site
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Krakow, Polonia, 31-115
- GSK Investigational Site
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Kraków, Polonia, 31-108
- GSK Investigational Site
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Olsztyn, Polonia, 10-228
- GSK Investigational Site
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Olsztyn, Polonia, 10-226
- GSK Investigational Site
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Poznan, Polonia, 60-569
- GSK Investigational Site
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Warszawa, Polonia, 00-909
- GSK Investigational Site
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Bebington, Wirral, Regno Unito, CH63 4JY
- GSK Investigational Site
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Belfast, Regno Unito, BT9 7AB
- GSK Investigational Site
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Swansea, Regno Unito, SA2 8QA
- GSK Investigational Site
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Devon
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Exeter, Devon, Regno Unito, EX2 5DW
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Lancashire
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Manchester, Lancashire, Regno Unito, M20 4BX
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Brno, Repubblica Ceca, 656 53
- GSK Investigational Site
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Chomutov, Repubblica Ceca, 430 12
- GSK Investigational Site
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Ostrava - Poruba, Repubblica Ceca, 708 52
- GSK Investigational Site
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Praha 2, Repubblica Ceca, 12808
- GSK Investigational Site
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Bratislava, Slovacchia, 833 10
- GSK Investigational Site
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Sfax, Tunisia, 3000
- GSK Investigational Site
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Sousse, Tunisia, 4054
- GSK Investigational Site
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Tunis, Tunisia, 1007
- GSK Investigational Site
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Tunis, Tunisia, 1008
- GSK Investigational Site
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Donetsk, Ucraina, 83092
- GSK Investigational Site
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Kharkiv, Ucraina, 61037
- GSK Investigational Site
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Kyiv, Ucraina, 03115
- GSK Investigational Site
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Lviv, Ucraina, 79031
- GSK Investigational Site
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Zaporizhzhya, Ucraina, 69600
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
A patient will be considered for inclusion in this study only if all of the following criteria apply:
- Signed written informed consent.
- Diagnosis of clear cell RCC that is predominantly clear cell histology. Note: cytology cannot be the only pathologic criteria to confirm clear cell RCC. Patients with tumor types that are interpreted as non-clear cell, e.g. papillary, are excluded.
- Locally advanced RCC (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer (AJCC) staging.
- Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology. Cytology cannot be the only pathologic criteria to confirm clear cell RCC, but can be used in a patient with histologically confirmed clear cell RCC to confirm that metastatic disease is neoplastic in nature.
- Must have measurable disease, i.e. presenting with at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST). A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques, or ≥ 10 mm with spiral CT scan.
- Note: Patient should be excluded if all baseline measurable lesions are within previously irradiated areas.
- Note: A patient must complete all the baseline disease assessments in order to be eligible. Baseline head, chest, abdominal and pelvic CT or MRI scans must be performed within 2 weeks prior to the first dose of study medication; baseline bone scan must be performed within 3 weeks of the first dose of study medication.
- Patients who have received only one prior systemic treatment for locally advanced or metastatic RCC with documented disease progression or documented treatment discontinuation due to unacceptable toxicity. This first-line systemic treatment must be cytokine based.
- Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-α (INFα) monotherapy, IL-2 in combination with INF-α, IL-2 and/or INF-α in combination with chemotherapy, hormonal or other therapies excluding agents targeting angiogenesis pathways. Agents in a combination regimen can be given sequentially if the treatment sequence is pre-determined and the patient does not fail one agent prior to starting another.
- Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that target vascular endothelial growth factor (VEGF) or VEGF receptors. The adjuvant/neo-adjuvant therapies should not be considered as first-line systemic treatment for advanced RCC.
Or,
- Patients who have received no prior systemic therapy for advanced/metastatic RCC can be enrolled if under any of the following circumstances:
- Patients who live in countries or regions where there is no established standard first-line therapy for advanced/metastatic RCC or where there are barriers to the access of established therapies such as sunitinib, sorafenib, IFNα or IL-2.
- Patients who live in countries or regions where IL-2 or INF-α has been approved for the treatment of advanced/metastatic RCC, however, these agents are generally not recognized by the local clinical community as a standard treatment for advanced/metastatic RCC, or where the physician and the patient have determined that the available cytokine therapies are not an acceptable therapeutic option.
- Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy for RCC are eligible to participate without receiving a first-line systemic treatment for locally advanced or metastatic RCC. These patients should be stratified as the first-line population.
- Male or female ≥ 18 years of age.
- A woman is eligible to participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- Has had a hysterectomy,
- Has had a bilateral oophorectomy (ovariectomy),
- Has had a bilateral tubal ligation,
- Is post-menopausal (total cessation of menses for ≥1 year).
- Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of study medication, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
- An intrauterine device with a documented failure rate of less than 1% per year.
- Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female.
- Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 21 days after the last dose of investigational product.
- Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
- Oral contraceptives are not reliable due to the potential for drug-drug interactions.
- A man with a female partner of childbearing potential is eligible to enter and participate in the study if he is abstinent or uses a barrier method of contraception during the study.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
- Adequate baseline organ function defined as:
- Hematologic function:
Absolute Neutrophil Count (ANC) ≥1 x 10^9/L Hemoglobin ≥ 9 g/dL Platelet ≥75 x 10^9/L
- Hepatic function:
Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≥ 2 x ULN
- Renal function:
Calculated creatinine clearance≥30 mL/min [See Section 14.6 Appendix 6] and
≥Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis.
- Note: A patient should first be screened with dipstick urinalysis. If urine protein is ≥2+, then a 24-hour urine protein must be assessed and patient will be excluded if 24-hour urine protein is≥ 1.0 gram.
- Corrected serum calcium level within normal range per local clinical laboratory standard.
Note: Patients with hypercalcemia should be treated until the corrected serum calcium level reaches the normal range.
- At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy or the last systemic cytokine therapy.
- Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy.
- Note: In patients with prior radiotherapy, the steroid doses should be stable or decreasing for at least 2 weeks.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- Pregnant or lactating female.
- History of another malignancy.
- Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam.
Note: A baseline brain CT or MRI scan must be obtained in all patients within 2 weeks of the first dose of study medication.
- Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib.
- Unable to swallow and retain orally administered medication.
- 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 4 weeks prior to beginning study treatment.
- History of human immunodeficiency virus infection.
- Presence of uncontrolled infection.
- Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.
- History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification.
- History of any one of the following cardiac conditions within the past 6 months:
- Cardiac angioplasty or stenting, or
- Myocardial infarction, or
- Unstable angina.
- History of cerebrovascular accident within the past 6 months.
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140mmHg, or diastolic blood pressure (DBP) of ≥ 90mmHg].
- Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP / DBP values from both blood pressure assessments must be < 140/90mmHg in order for a patient to be eligible for the study.
- History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. a calf vein thrombosis that is not treated).
Note: Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin) for at least 2 weeks are eligible.
- Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
- Has taken any prohibited medications within 14 days of the first dose of study medication.
- Current or prior use of an investigational anti-cancer drug within 4 weeks of start of study.
- Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: placebo arm
matching placebo (800 mg tablet) once daily
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matching placebo (800 mg tablet) once daily
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Sperimentale: pazopanib arm
Oral pazopanib tablet 800 mg once daily continuously
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Oral pazopanib tablet 800 mg once daily continuously
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression-free Survival
Lasso di tempo: Randomization until progression (up to 2 years)
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Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause.
Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.
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Randomization until progression (up to 2 years)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Survival
Lasso di tempo: Randomization until death (up to 2 years)
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Overall survival is defined as the time from randomization until death.
The length of this interval was estimated as the date of death minus the date of randomization plus 1 day.
Participants who were still alive at the time of analysis were censored.
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Randomization until death (up to 2 years)
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Overall Response
Lasso di tempo: Baseline until either response or progression (up to 2 years)
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Overall response is the number of participants who had a complete response (CR) or a partial response (PR).
Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria.
IRC, independent review committee.
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Baseline until either response or progression (up to 2 years)
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Participants With Complete Response, Partial Response, or 6 Months of Stable Disease
Lasso di tempo: Baseline until 6 months post-Baseline or progressive disease
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This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months.
Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a >=20% increase in target lesions.
IRC, independent review committee.
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Baseline until 6 months post-Baseline or progressive disease
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Duration of Response
Lasso di tempo: Time from response until progression (up to 2 years)
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Duration of response is defined as the time from first observation of response until progression of disease or death.
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Time from response until progression (up to 2 years)
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Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator
Lasso di tempo: Randomization until CR or PR (assessed for up to 2 years)
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Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).
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Randomization until CR or PR (assessed for up to 2 years)
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Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48
Lasso di tempo: Baseline and Weeks 6, 12, 18, 24, and 48
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The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants.
The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire.
The scores (from 1 [very poor quality of life] to 7 [excellent quality of life]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.
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Baseline and Weeks 6, 12, 18, 24, and 48
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Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
Lasso di tempo: Baseline and Weeks 6, 12, 18, 24, and 48
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The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression.
Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems).
Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS).
Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (<0).
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Baseline and Weeks 6, 12, 18, 24, and 48
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Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
Lasso di tempo: Baseline and Weeks 6, 12, 18, 24, and 48
|
The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression.
Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems).
Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale.
The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).
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Baseline and Weeks 6, 12, 18, 24, and 48
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Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3
Lasso di tempo: Day 1 and Week 3
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The concentration of pazopanib in the plasma was measured.
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Day 1 and Week 3
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Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants
Lasso di tempo: Baseline
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Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors.
Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.
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Baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.
- Bonate PL, Suttle AB. Modeling tumor growth kinetics after treatment with pazopanib or placebo in patients with renal cell carcinoma. Cancer Chemother Pharmacol. 2013 Jul;72(1):231-40. doi: 10.1007/s00280-013-2191-0. Epub 2013 May 29.
- Tran HT, Liu Y, Zurita AJ, Lin Y, Baker-Neblett KL, Martin AM, Figlin RA, Hutson TE, Sternberg CN, Amado RG, Pandite LN, Heymach JV. Prognostic or predictive plasma cytokines and angiogenic factors for patients treated with pazopanib for metastatic renal-cell cancer: a retrospective analysis of phase 2 and phase 3 trials. Lancet Oncol. 2012 Aug;13(8):827-37. doi: 10.1016/S1470-2045(12)70241-3. Epub 2012 Jul 2.
- Maitland ML, Wu K, Sharma MR, Jin Y, Kang SP, Stadler WM, Karrison TG, Ratain MJ, Bies RR. Estimation of renal cell carcinoma treatment effects from disease progression modeling. Clin Pharmacol Ther. 2013 Apr;93(4):345-51. doi: 10.1038/clpt.2012.263. Epub 2012 Dec 27.
- Xu CF, Reck BH, Goodman VL, Xue Z, Huang L, Barnes MR, Koshy B, Spraggs CF, Mooser VE, Cardon LR, Pandite LN. Association of the hemochromatosis gene with pazopanib-induced transaminase elevation in renal cell carcinoma. J Hepatol. 2011 Jun;54(6):1237-43. doi: 10.1016/j.jhep.2010.09.028. Epub 2011 Feb 12.
- Xu CF, Reck BH, Xue Z, Huang L, Baker KL, Chen M, Chen EP, Ellens HE, Mooser VE, Cardon LR, Spraggs CF, Pandite L. Pazopanib-induced hyperbilirubinemia is associated with Gilbert's syndrome UGT1A1 polymorphism. Br J Cancer. 2010 Apr 27;102(9):1371-7. doi: 10.1038/sj.bjc.6605653. Epub 2010 Apr 13.
- Sternberg CN, Hawkins RE, Wagstaff J, Salman P, Mardiak J, Barrios CH, Zarba JJ, Gladkov OA, Lee E, Szczylik C, McCann L, Rubin SD, Chen M, Davis ID. A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: final overall survival results and safety update. Eur J Cancer. 2013 Apr;49(6):1287-96. doi: 10.1016/j.ejca.2012.12.010. Epub 2013 Jan 12.
- Goldstein D, Rosenberg JE, Figlin RA, Townsend RR, McCann L, Carpenter C, Pandite L. Is change in blood pressure a biomarker of pazopanib and sunitinib efficacy in advanced/metastatic renal cell carcinoma? Eur J Cancer. 2016 Jan;53:96-104. doi: 10.1016/j.ejca.2015.10.006. Epub 2015 Dec 15.
- Sorich MJ, Kichenadasse G, Rowland A, Woodman RJ, Mangoni AA. Angiotensin system inhibitors and survival in patients with metastatic renal cell carcinoma treated with VEGF-targeted therapy: A pooled secondary analysis of clinical trials. Int J Cancer. 2016 May 1;138(9):2293-9. doi: 10.1002/ijc.29972. Epub 2016 Jan 6.
- Suttle AB, Ball HA, Molimard M, Hutson TE, Carpenter C, Rajagopalan D, Lin Y, Swann S, Amado R, Pandite L. Relationships between pazopanib exposure and clinical safety and efficacy in patients with advanced renal cell carcinoma. Br J Cancer. 2014 Nov 11;111(10):1909-16. doi: 10.1038/bjc.2014.503. Epub 2014 Oct 28. Erratum In: Br J Cancer. 2014 Dec 9;111(12):2383.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2006
Completamento primario (Effettivo)
1 maggio 2008
Completamento dello studio (Effettivo)
1 dicembre 2014
Date di iscrizione allo studio
Primo inviato
5 giugno 2006
Primo inviato che soddisfa i criteri di controllo qualità
5 giugno 2006
Primo Inserito (Stima)
7 giugno 2006
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
5 febbraio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 gennaio 2016
Ultimo verificato
1 agosto 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VEG105192
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .