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Carcinoma, Renal CellPhase 3PISCESNCT01064310

Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer

A Phase 3 study testing pazopanib and sunitinib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 51 sites in 5 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

This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. 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 and sunitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
51 sitesin 5 countries
Study dates
17 May 2010to 23 Nov 2015
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

  • Patients must provide written informed consent prior to performance of any study-specific procedures or assessments and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging study) and obtained prior to signing of informed consent may be utilised for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
  • Received no prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with a cancer vaccine are eligible.
  • Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging). Patients with non-measurable disease are allowed if metastatic disease can be confirmed.
  • ECOG PS of 0 or 1
  • Age >= 18 years
  • A female is eligible to enter and participate in this study if she is of:
Show all 11Show fewer
  • Non-childbearing potential (i.e. physiologically incapable of becoming pregnant) Childbearing potential, including any female who has had a negative serum pregnancy test within two weeks prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception.
  • Adequate organ system functions
  • Total serum calcium concentration <12.0mg/dL
  • Left ventricular ejection fraction (LVEF) >=lower limit of institutional normal (LLN) as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan. The same modality used at baseline must be applied for subsequent evaluations.
  • Patient is able to swallow and retain oral tablets

Who cannot join

  • Poor MSKCC risk group
  • History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 3 years or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
  • History or clinical evidence of central nervous system (CNS) metastases.
  • Note: Patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:
  • Are asymptomatic,
  • Have had no evidence of active CNS metastases for >=6 months prior to enrolment ,
Show all 37Show fewer
  • Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC).
  • Any clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or affect absorption of investigational product including, but not limited to:
  • 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.
  • Presence of uncontrolled infection.
  • Corrected QT interval (QTc) >480 msecs using Bazett's formula
  • History of one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery bypass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension (defined as systolic blood pressure (SBP) of > 150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline.
  • Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour within a visit. The mean SBP/DBP values from each blood pressure assessment must be <=150/90mmHg in order for a patient to be eligible for the study.
  • History of cerebrovascular accident (CVA) including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
  • Evidence of active bleeding or bleeding diathesis.
  • Significant haemoptysis within 6 weeks prior to first dose of study drug.
  • 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.
  • Use any prohibited medications within 14 days of the first dose of study medication.
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
  • Radiation therapy, surgery or tumour embolisation within 14 days prior to the first dose of study treatment.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib.
  • Pregnant or lactating female Female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.

Trial locations and contacts

51 sites in 5 countries.

51 sites in 5 countries

France15 sites

  • Novartis Investigative Site

    Angers, 49933

  • Novartis Investigative Site

    Bordeaux, 33075

  • Novartis Investigative Site

    Caen, 14076

  • Novartis Investigative Site

    Colmar, 68024

  • Novartis Investigative Site

    Hyères, 83400

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Paris, 75908

  • Novartis Investigative Site

    Rennes, 35042

  • Novartis Investigative Site

    Rouen, 76031

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42271

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Italy11 sites

  • Novartis Investigative Site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Novartis Investigative Site

    Bergamo, Lombardy, 24128

  • Novartis Investigative Site

    Chieti, 66100

  • Novartis Investigative Site

    Lecce, Apulia, 73100

  • Novartis Investigative Site

    Lido Di Camaiore (LU), Tuscany, 55043

  • Novartis Investigative Site

    Meldola (FC), Emilia-Romagna, 47014

  • Novartis Investigative Site

    Monza, Lombardy, 20052

  • Novartis Investigative Site

    Pavia, Lombardy, 27100

  • Novartis Investigative Site

    Pisa, Tuscany, 56126

  • Novartis Investigative Site

    Rome, Lazio, 00152

  • Novartis Investigative Site

    Taormina, Sicily

Other trials in Italy

United Kingdom10 sites

  • Novartis Investigative Site

    Birmingham, B9 5SS

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Cottingham, HU16 5JQ

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN

  • Novartis Investigative Site

    Norwich, NR4 7UY

  • Novartis Investigative Site

    Plymouth, PL6 8DH

  • Novartis Investigative Site

    Preston, PR2 9HT

  • Novartis Investigative Site

    Shrewsbury, SY3 8XQ

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Germany9 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52074

  • Novartis Investigative Site

    Berlin, State of Berlin, 10117

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53127

  • Novartis Investigative Site

    Fürth, Bavaria, 90766

  • Novartis Investigative Site

    Goslar, Lower Saxony, 38642

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Neuss, North Rhine-Westphalia, 41462

  • Novartis Investigative Site

    Ravensburg, Baden-Wurttemberg, 88212

Other trials in Germany

Finland6 sites

  • Novartis Investigative Site

    Helsinki, 00029

  • Novartis Investigative Site

    Joensuu, 80210

  • Novartis Investigative Site

    Lahti, 15850

  • Novartis Investigative Site

    Seinäjoki, 60220

  • Novartis Investigative Site

    Turku, 20520

  • Novartis Investigative Site

    Vaasa, 65130

Other trials in Finland

About this study

Official title: A Randomised Double-blind Cross-over Patient Preference Study of Pazopanib Versus Sunitinib in Treatment naïve Locally Advanced or Metastatic Renal Cell Carcinoma.

This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.

Read the detailed description

This is a randomised, double-blind, cross-over study to evaluate the patient preference of pazopanib versus sunitinib in patients with locally advanced or metastatic RCC who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. 2+).

The study consists of two 10-weeks treatment periods with a two-week wash-out period between the treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially. At the end of the second treatment period, patient preference and disease assessment are evaluated and the patients are unblinded. Further treatment is at the discretion of the physician. Further treatment with pazopanib is available within the study. Patients requiring other treatments will complete the study at this point.

Patients will be randomized in a 1:1 ratio to receive blinded (overencapsulated) study drug: either 800mg pazopanib orally for 10 weeks followed by 50mg sunitinib orally for 10 weeks or 50mg sunitinib orally for 10 weeks followed by 800mg pazopanib orally for 10 weeks. A two-week washout period will separate the treatment periods (the medical monitor should be consulted if ongoing AEs need to be resolved and the wash-out period needs to be extended). The regimen for sunitinib is 4 weeks of treatment followed by 2 weeks off treatment. To maintain the double-blind during the two weeks off drug for patients on sunitinib ('Treatment Holiday'), patients will be taking matching placebo. No study drug will be taken during the wash-out period in either arm.

Following the two-week wash-out period and disease assessment, all patients are planned to cross over to the second treatment. Patients will be informed of their disease assessment result and any patient that wishes to come off study at this point due to a very significant response, defined as more than a 50% reduction in tumour size (or complete response if non-measurable disease), will have the option to be unblinded to continue with whichever treatment they were on, however each patient case will need to be discussed with the medical monitor prior to unblinding. Patients who were on sunitinib will leave the study and continue treatment outside the study. Patients who were on pazopanib will continue on pazopanib within the pazopanib open-label part of the study. Conversely, should a patient have a very significant response and wish to cross over or complete the study, this must be documented in the patients notes.

Patients crossing over with progressive disease will follow the same visit schedule and assessments and investigators will have the option for these patients to be unblinded or not. The patients' preference will be collected and analysed but will not contribute to the primary, but an exploratory analysis because of the bias caused by progressing on the first treatment. Even if unblinded, patients may continue to receive the second treatment and may receive open label pazopanib after the second treatment within the study if they did not progress on pazopanib.

Patients who withdraw from treatment due to unacceptable toxicity or progression during the first treatment period will cross-over directly to the second treatment following a 2-week wash-out period.

Actual further treatment at the end of the study will be at the discretion of the investigator taking into account both disease assessments results, laboratory results and the patient preference. Choice and rationale for continuing treatment will be documented.

Patients who did not progress on pazopanib and who prefer to continue with pazopanib may continue on pazopanib and will be followed up for safety until the patient comes off pazopanib due to disease progression, toxicity, death or patient choice, which ever is the earliest.

Those patients that may benefit from further treatment with sunitinib for the same reasons as above will receive it off study and will not be followed up, as will patients who receive any other treatment.

Patients are permitted to receive supportive care throughout the study including transfusion of blood and blood products, treatment with antibiotics, anti-emetics, anti-diarrhoeal agents, analgesics, erythropoietin or bisphosphonates, when appropriate. The study treatment will continue until the end of the two treatment periods or unacceptable toxicity or consent withdrawal or death, whichever occurs first.

The patient preference will be ascertained prior to the second disease assessment result being shared with the patient to avoid bias.

Being tested
pazopanib, sunitinib
Keywords
renal cell carcinoma, Votrient, cancer, pazopanib, patient preference, quality of life
Medical subject headings
Carcinoma, Renal Cell, Neoplasms, Patient Preference

What participants receive

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

  • pazopanibDrug

    Also called Votrient

    oral anti-angiogenic treatment

  • sunitinibDrug

    Also called Sutent

    oral anti-angiogenic treatment

Study groups in NCT01064310
Study groupRoleWhat they receive
pazopanib followed by sunitinibExperimental800mg pazopanib orally for 10 weeks followed by 50mg sunitinib orally for 10 weeks
Receives: Drug: pazopanib; Drug: sunitinib
sunitinib followed by pazopanibExperimental50mg sunitinib orally for 10 weeks followed by 800mg pazopanib orally for 10 weeks
Receives: Drug: pazopanib; Drug: sunitinib

What is being measured

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

  1. Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)

    The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.

    Measured: End of treatment of both study drugs (maximum of 22 weeks)

  2. Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire

    The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.

    Measured: End of treatment of both study drugs (maximum of 22 weeks)

Secondary outcomes (9)

  1. Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score

    Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.

    Measured: Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])

  2. Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores

    The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])

  3. Time to Dose Modification

    For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.

    Measured: End of second treatment period (maximum of 22 weeks)

  4. Number of Participants With the Indicated Number of Dose Reductions

    Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.

    Measured: End of second treatment period (maximum of 22 weeks)

  5. Number of Participants With the Indicated Reason for Receiving a Dose Reduction

    Dose reduction of study drug was a stepwise reduction of the dose of the study drug: one less capsule was received at each step reduction. Participants were monitored for approximately 10 to 14 days at each dose level. Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.

    Measured: End of second treatment period (maximum of 22 weeks)

  6. Number of Participants With Grade 1 to Grade 5 Adverse Events (AEs)

    AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.

    Measured: Baseline to end of study (maximum of 22 weeks)

  7. Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Treatment

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE that spans more than one period is considered to be an AE for each period during which the AE increased in grade. There is only one action with respect to study drug recorded for the whole event. As such, it is not always possible to determine in which study period treatment was discontinued due to the AE.

    Measured: Baseline to end of study (maximum of 22 weeks)

  8. Change From Baseline (BL) in Systolic Blood Pressure (SBP) and Diastolic BP (DBP)

    When the heart beats, it contracts and pushes blood through the arteries to the rest of body. This force creates pressure on the arteries called SBP. DBP is the pressure in the arteries when the heart rests between beats. Normal levels: SBP (120 mmHg or less); DBP (80 mmHg or less). Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.

    Measured: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)

  9. Change From Baseline (BL) in Heart Rate

    Heart rate (HR) is the number of heartbeats per unit of time, typically expressed as beats per minute. HR can vary as the body's need to absorb oxygen and excrete carbon dioxide changes, such as during exercise or sleep. A normal resting HR ranges from 60 to 100 beats per minute. Mean change from BL for each assessment week was calculated as the average change from period BL at the specified visits (combining data across P 1 and 2 for Weeks 2 and 6). Study weeks are approximate; participants could have crossed over from P 1 to P 2 at earlier time points than specified in the protocol.

    Measured: Baseline of Period (P) 1 (Screening); Period 1 Weeks 2 and 6 (Study Weeks 2 and 6); Baseline of Period 2 (Washout=Study Week 12); Period 2 Weeks 2, 6, and 10 (Study Weeks 14, 18, and 22)

Timeline

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

  1. First posted8 Feb 2010 (estimated)
  2. Study start17 May 2010
  3. Primary completion19 Oct 2011
  4. Study completion23 Nov 2015

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064310
Sponsor's protocol ID
113046
Acronym
PISCES
Status last verified
Mar 2017
First submitted
4 Feb 2010
Last updated
17 Apr 2017
Data monitoring committee
No

Publications

  • 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

  • Oudard S, Benhamouda N, Escudier B, Ravel P, Tran T, Levionnois E, Negrier S, Barthelemy P, Berdah JF, Gross-Goupil M, Sternberg CN, Bono P, Porta C, De Giorgi U, Parikh O, Hawkins R, Highley M, Wilke J, Decker T, Tanchot C, Gey A, Terme M, Tartour E. Decrease of Pro-Angiogenic Monocytes Predicts Clinical Response to Anti-Angiogenic Treatment in Patients with Metastatic Renal Cell Carcinoma. Cells. 2021 Dec 22;11(1):17. doi: 10.3390/cells11010017.

    PubMed 35011579

  • Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.

    PubMed 26457466

  • Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Negrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014 May 10;32(14):1412-8. doi: 10.1200/JCO.2013.50.8267. Epub 2014 Mar 31.

    PubMed 24687826

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pazopanib and sunitinib in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 51 sites in 5 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 11 inclusion and 37 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 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in France, Italy, United Kingdom, Germany, Finland. 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. 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 23 Aug 2012). 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?

Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ) (time frame: End of treatment of both study drugs (maximum of 22 weeks)). The study lists 2 primary outcomes in all. 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 NCT01064310, which also lists 4 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 17 Apr 2017.

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