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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-004024-37
    Sponsor's Protocol Code Number:A6181109
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004024-37
    A.3Full title of the trial
    SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC
    A.3.2Name or abbreviated title of the trial where available
    S-TRAC
    A.4.1Sponsor's protocol code numberA6181109
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc. - 235 East 42nd Street - New York - 10017
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    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 Yes
    D.2.1.1.1Trade name Sutent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU73/05/268
    D.3 Description of the IMP
    D.3.1Product nameSutent
    D.3.2Product code SU011248
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 341031-54-7
    D.3.9.2Current sponsor codeSU-0011248
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adjuvant treatment of subjects with “high risk” Renal Cell Carcinoma (RCC) following nephrectomy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10038408
    E.1.2Term Renal cell carcinomas
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate an improvement in disease-free survival (DFS) in high risk (per modified UISS criteria) subjects with RCC randomly assigned to adjuvant sunitinib 50 mg schedule 4/2: 4 weeks on, 2 weeks off for 1 year (Arm A), vs. Placebo (Arm B) after nephrectomy.
    E.2.2Secondary objectives of the trial
    Compare overall survival (OS) associated with Arm A to that associated with Arm B

    Assess safety/toxicity profile of schedule 4/2: 4 weeks on, 2 weeks off administration of sunitinib

    Assess patient reported outcomes (PROs)

    Assess the UISS Prognostic Model
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects must sign and date IRB/IEC-approved informed consent
    2.Age ≥ 18 years
    3.ECOG Performance Status 0 – 2 prior to nephrectomy
    4.Subjects must be diagnosed in the high risk UISS staging system with one of the following:
    a.T3 N0 or Nx, M0, Fuhrman’s grade ≥ 2 and ECOG general status ≥ 1, or
    b.T4 N0 or Nx, M0, any Fuhrman’s grade and any ECOG general status, or
    c.Any T, N1-2, M0, any Fuhrman’s grade and any ECOG general status
    5.Subjects must have histologically confirmed preponderant clear cell RCC
    6.Subjects must have no evidence of macroscopic residual disease or metastatic disease Subjects having evidence for microscopic disease (R1) are acceptable
    7.Subjects must not have received any specific medical previous systemic treatment for RCC
    8.Subjects must not have received any previous anti-angiogenic treatment
    9.Subjects must receive the first oral dose of sunitinib not more than 10 weeks after date of nephrectomy (see Appendix 6 for Nephrectomy Procedure).
    10.Subjects must have adequate organ function defined as:
    a.Platelets ≥ 100 x 10e9/L, hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥1.5 x 10e9/L;
    b.Bilirubin ≤ 3 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal
    c. International Normalize Ratio (INR) ≤ 1.7 or Prothrombin time (PT) ≤ 6 sec over
    d.Calculated creatinine clearance ≥ 30 ml/min.
    11.Sufficient left ventricular ejection function (LVEF) defined as ≥50% 3 to 10 weeks after date of nephrectomy based on 2-D echocardiogram (ECHO) or multigated acquisition MUGA
    12.Women and men must use adequate contraception during the study. Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner or vasectomy.
    13.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1.Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
    2.NCI CTCAE grade 3 hemorrhage <4 weeks of date of randomization.
    3.Diagnosis of any second malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
    4.Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
    5.Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing before 7 and 12 days before date of randomization (e.g., ketoconazole, rifampin, etc. respectively).
    6.Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 500 msec.
    7.Hypertension that cannot be controlled by medications.
    8.Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin currently or within 2 weeks prior to first day of sunitinib administration. Low dose warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (up to 2 mg/day). Low molecular weight heparin or aspirin are allowed.
    9.Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
    10.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
    11.Known active hepatitis.
    12.Pregnancy or breastfeeding. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to date of randomization.
    13.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 may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
    14.Receipt of any investigational oncology or, approved or investigational anti-angiogenic agent prior to study entry.
    15.Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials, e.g. PRO methods studies, are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Disease Free Survival: (DFS), defined as the time interval from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. The primary DFS analysis will be based on independent blinded 3rd party review. A secondary analysis of DFS will be based on the local investigator assessment.

    Recurrence refers to relapse of the primary tumor in-situ or at metastatic sites. The date of recurrence or occurrence of a secondary malignancy is defined as the date of the independent blinded 3rd party review confirms recurrence or occurrence of a secondary malignancy for the first time.

    For subjects receiving further anti-tumor therapy before disease recurrence or occurrence of a secondary malignancy or death, the subjects will be assigned with DFS events at the first date of recurrence or occurrence of a second primary cancer or death. In the absence of DFS event, DFS time will be censored at the date of last disease assessment or cutoff date, whichever come first. Subjects alive who do not have post baseline disease assessment will have their DFS times censored at Day 1.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    QoL
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 Trial in a Member State (MS) of the EU is defined as the time at which it is deemed that sufficient subjects have been recruited and completed the trial or withdrawn or died, and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a MS is not a reason for premature termination but is considered a normal conclusion to the trial in that MS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 205
    F.4.2.2In the whole clinical trial 275
    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)
    Please refer to section 6.3 of the Protocol.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-30
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