AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT00334282

Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma

A Phase 3 study testing Pazopanib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 99 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Pazopanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
435 participants
Where
99 sitesin 25 countries
Study dates
Apr 2006to Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

99 sites in 25 countries.

99 sites in 25 countries

Russia10 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Kazan', 420029

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 117 837

  • GSK Investigational Site

    Moscow, 129 128

  • GSK Investigational Site

    Omsk, 644013

  • GSK Investigational Site

    Saint Petersburg, 198255

  • GSK Investigational Site

    Samara, 443066

  • GSK Investigational Site

    Voronezh, 394062

  • GSK Investigational Site

    Yaroslavl, 150054

Other trials in Russia

Italy7 sites

  • GSK Investigational Site

    Casalpusterlengo (LO), Lombardy, 26841

  • GSK Investigational Site

    Crema, Lombardy, 26013

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Orbassano (TO), Piedmont, 10043

  • GSK Investigational Site

    Rome, Lazio, 00133

  • GSK Investigational Site

    Rome, Lazio, 00152

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

Poland7 sites

  • GSK Investigational Site

    Gdansk, 80-210

  • GSK Investigational Site

    Krakow, 31-108

  • GSK Investigational Site

    Krakow, 31-115

  • GSK Investigational Site

    Olsztyn, 10-226

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Warsaw, 00-909

Other trials in Poland

Greece6 sites

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 115 26

  • GSK Investigational Site

    Athens, 115 28

  • GSK Investigational Site

    Athens, 185 37

  • GSK Investigational Site

    Pátrai, 26500

  • GSK Investigational Site

    Thessaloniki, 564 29

Other trials in Greece

Argentina5 sites

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1405CUB

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Quilmes, 1878

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Australia5 sites

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

  • GSK Investigational Site

    Waratah, New South Wales, 2298

  • GSK Investigational Site

    Wodonga, Victoria, 3690

Other trials in Australia

India5 sites

  • GSK Investigational Site

    Bangalore, 560029

  • GSK Investigational Site

    Hyderabad, 500033

  • GSK Investigational Site

    Mumbai, 400026

  • GSK Investigational Site

    Pune, 411 004

  • GSK Investigational Site

    Trivandrum, 695011

Other trials in India

Ukraine5 sites

  • GSK Investigational Site

    Donetsk, 83092

  • GSK Investigational Site

    Kharkiv, 61037

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Lviv, 79031

  • GSK Investigational Site

    Zaporizhzhya, 69600

Other trials in Ukraine

United Kingdom5 sites

  • GSK Investigational Site

    Bebington, Wirral, CH63 4JY

  • GSK Investigational Site

    Belfast, BT9 7AB

  • GSK Investigational Site

    Exeter, Devon, EX2 5DW

  • GSK Investigational Site

    Manchester, Lancashire, M20 4BX

  • GSK Investigational Site

    Swansea, SA2 8QA

Other trials in United Kingdom

Austria4 sites

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, 1130

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1100

Other trials in Austria

Czechia4 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Chomutov, 430 12

  • GSK Investigational Site

    Ostrava - Poruba, 708 52

  • GSK Investigational Site

    Prague, 12808

Other trials in Czechia

Tunisia4 sites

  • GSK Investigational Site

    Sfax, 3000

  • GSK Investigational Site

    Sousse, 4054

  • GSK Investigational Site

    Tunis, 1007

  • GSK Investigational Site

    Tunis, 1008

Other trials in Tunisia

Brazil3 sites

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30150-270

  • GSK Investigational Site

    Jaú, São Paulo, 17210-120

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610 000

Other trials in Brazil

Chile3 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500921

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7591046

  • GSK Investigational Site

    Viña del Mar, Valparaiso, 254-0364

Other trials in Chile

Hong Kong3 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Tuen Mun, New Territories

Other trials in Hong Kong

Lithuania3 sites

  • GSK Investigational Site

    Kaunas, LT-50009

  • GSK Investigational Site

    Klaipėda, LT-92228

  • GSK Investigational Site

    Vilnius, LT-08660

Other trials in Lithuania

Mexico3 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, CP44280

  • GSK Investigational Site

    Mérida, Yucatán, 97500

  • GSK Investigational Site

    Mexico City, CP 14080

Other trials in Mexico

New Zealand3 sites

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Newtown, Wellington, 6002

  • GSK Investigational Site

    Palmerston North, 4414

Other trials in New Zealand

Pakistan3 sites

  • GSK Investigational Site

    Islamabad, 1590

  • GSK Investigational Site

    Karachi, 74800

  • GSK Investigational Site

    Lahore, 54600

Other trials in Pakistan

South Korea3 sites

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

China2 sites

  • GSK Investigational Site

    Beijing, 100034

  • GSK Investigational Site

    Beijing, 100853

Other trials in China

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 11619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Ireland2 sites

  • GSK Investigational Site

    Galway

  • GSK Investigational Site

    Tallaght, Dublin, 24

Other trials in Ireland

Latvia1 site

  • GSK Investigational Site

    Riga, LV 1002

Other trials in Latvia

Slovakia1 site

  • GSK Investigational Site

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: 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.

Being tested
Pazopanib, placebo
Keywords
Metastatic, Anti-angiogenesis, GW786034, Pazopanib
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called votrient

    Oral pazopanib tablet 800 mg once daily continuously

  • placeboDrug

    matching placebo (800 mg tablet) once daily

Study groups in NCT00334282
Study groupRoleWhat they receive
placebo armPlacebo comparatormatching placebo (800 mg tablet) once daily
Receives: Drug: placebo
pazopanib armExperimentalOral pazopanib tablet 800 mg once daily continuously
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    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.

    Measured: Randomization until progression (up to 2 years)

Secondary outcomes (10)

  1. Overall Survival

    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.

    Measured: Randomization until death (up to 2 years)

  2. Overall Response

    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.

    Measured: Baseline until either response or progression (up to 2 years)

  3. Participants With Complete Response, Partial Response, or 6 Months of Stable Disease

    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.

    Measured: Baseline until 6 months post-Baseline or progressive disease

  4. Duration of Response

    Duration of response is defined as the time from first observation of response until progression of disease or death.

    Measured: Time from response until progression (up to 2 years)

  5. Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator

    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).

    Measured: Randomization until CR or PR (assessed for up to 2 years)

  6. 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

    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.

    Measured: Baseline and Weeks 6, 12, 18, 24, and 48

  7. 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

    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).

    Measured: Baseline and Weeks 6, 12, 18, 24, and 48

  8. 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

    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).

    Measured: Baseline and Weeks 6, 12, 18, 24, and 48

  9. Plasma Pazopanib Concentrations Before Dosing and at 2, 4, and 8 Hours After Dosing on Day 1 and Week 3

    The concentration of pazopanib in the plasma was measured.

    Measured: Day 1 and Week 3

  10. Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionMay 2008
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334282
Sponsor's protocol ID
VEG105192
Status last verified
Aug 2015
First submitted
5 Jun 2006
Last updated
5 Feb 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23715625

  • 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.

    PubMed 22759480

  • 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.

    PubMed 20100962

  • 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.

    PubMed 23443753

  • 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.

    PubMed 21145803

  • 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.

    PubMed 20389299

  • 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.

    PubMed 23321547

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

  • 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.

    PubMed 26702763

  • 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.

    PubMed 26685869

  • 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.

    PubMed 25349968

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pazopanib in people with Carcinoma, Renal Cell, run by GlaxoSmithKline at 99 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Russia, Italy, Poland, Greece, Argentina and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Randomization until progression (up to 2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334282, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.

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