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    Summary
    EudraCT Number:2005-004502-82
    Sponsor's Protocol Code Number:SUN1972
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-004502-82
    A.3Full title of the trial
    A Phase II Study of Neoadjuvant Sunitinib in Metastatic Renal Cell Carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study looking at sunitinib treatment in patients with Renal Cell Cancer that has spread to other areas of the body.
    A.3.2Name or abbreviated title of the trial where available
    NeoSun
    A.4.1Sponsor's protocol code numberSUN1972
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCambridge University Hospitals NHS Foundation Trust and University of Cambridge
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSunitinib Malate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSunitinib Malate
    D.3.9.1CAS number 557795-19-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12.5 to 50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Renal Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Renal Cell cancer that has spread
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the anti-tumour activity of sunitinib when given before and after nephrectomy to previously untreated patients with metastatic renal cell carcinoma
    E.2.2Secondary objectives of the trial
    To describe the toxic effects of sunitinib given before and after nephrectomy until disease progression to previously untreated patients with metastatic renal cell carcinoma

    To evaluate, pathologically, evidence of sunitinib activity in the primary RCC lesion

    To correlate pathological response with clinical response

    To identify in vivo targets for sunitinib in renal cell cancer by analysis of tumour samples prior to and during therapy

    To correlate changes in serum and tumour biomarkers with both response to treatment and toxicity

    To evaluate changes in diffusion weighted (DWI-MRI), BOLD and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) of the tumour before and after 12 days of sunitinib therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Presumed metastatic (Stage IV) renal cell carcinoma, as defined by the referring clinician
    • Clinically fit and scheduled for nephrectomy
    • No prior systemic therapy for renal cell carcinoma
    • Male or female, 18 years of age or older
    • Life expectancy of 12 weeks or greater
    • ECOG performance status 0 or 1
    • Radiologically documented, RECIST measurable, metastatic disease. Measurable disease, defined by the presence of at least one lesion outside of the kidney which can be measured in at least one dimension with the longest diameter ≥ 20mm using chest X-ray, ≥ 10mm calliper measurement by clinical exam or ≥ 10mm using spiral CT.
    • Laboratory parameters as follows:
    o Serum aspartate transaminase (AST) or serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST or ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy
    o Total serum bilirubin ≤1.5 x ULN
    o Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
    o Platelets ≥100 x 10^9/L
    o Haemoglobin ≥90 g/L (However where a transfusion is scheduled the patient may have a lower a value but this must be discussed and approved)
    o Serum creatinine ≤1.5 x ULN
    o Prothrombin time (PT) ≤1.5 x ULN
    • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
    • Before patient registration, written informed consent, including for preoperative biopsy, must be given according to ICH/GCP, national and local regulations
    E.4Principal exclusion criteria
    • Presence of ≥ grade 3 (NCI CTCAE grading version 3.0) haemorrhage within 4 weeks of registration.
    • Any previous chemotherapy or investigational treatment given for renal carcinoma.
    • Diagnosis of any other malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
    • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
    • Any major surgery in the previous 4 weeks.
    • Co-administration of CYP3A4 inducer or inhibitor medications that would require an increase or decrease in sunitinib dosage from the study dose of 50 mg o.d.
    • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    • Ongoing cardiac dysrhythmias of ≥ grade 2 (NCI CTCAE grading version 3.0), atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females
    • Treatment with drugs of dysrhythmic potential is not allowed
    • Concurrent participation in another clinical trial using an investigational medicinal product
    • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
    • Pregnancy or breastfeeding.
    • Female patients must be surgically sterile, be postmenopausal, or must agree to use effective contraception during the period of therapy and for 6 months after. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after. Barrier contraception is recommended.
    • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial.
    • Uncontrolled hypertension. Patients are excluded with current blood pressure of either systolic ≥ 150 or diastolic ≥90. Patients using anti-hypertensive medication to control blood pressure to these levels are elgible.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is objective response rate.
    E.5.2Secondary end point(s)
    • Objective clinical benefit rate (by RECIST criteria) of sunitinib
    • Pathological response as measured by % tumour necrosis
    • Morbidity and mortality related to sunitinib intra-operatively and post-operatively e.g. risk of bleeding, thrombosis, delayed wound healing, sepsis
    • Time to hospital discharge post-nephrectomy
    • Response rate, overall survival, time to progression and response duration
    • Toxicity of sunitinib (by NCI CTCAE grading version 3.0)
    • Expression of all major VEGF isoforms, PDGFR, c-KIT and FLT-3 in tissue samples as measured by RT-PCR and Western blotting
    • VEGF-A and VEGF-C levels in serum as measured by ELISA
    • VHL, PTEN and RAS typing on tumour
    • To evaluate changes in diffusion weighted (DWI-MRI), BOLD and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) of the tumour before and after 12 days of sunitinib therapy
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the date of the last visit of the last patient undergoing assessment for the end of the study procedures / patient withdrawal. Collection of follow up and survival data will continue after this time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue on treatment for as long as they recieve clinical benefit. Should a patient come off trial for any adverse reason, alternative clinical interventions may be considered/sought.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-12-22
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