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    Summary
    EudraCT Number:2009-014336-38
    Sponsor's Protocol Code Number:2009-02-SUN-Case
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-014336-38
    A.3Full title of the trial
    A randomized, placebo-controlled phase II trial investigating SUNITINIB versus placebo in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus treated with chemotherapy FOLFIRI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial for treatment of advanced cancer of the lower esophagus and stomach, with the Sunitinib or Placebo in addition to standard therapy
    A.3.2Name or abbreviated title of the trial where available
    SUN-CASE
    A.4.1Sponsor's protocol code number2009-02-SUN-Case
    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 SponsorUniversitätsmedizin der Johannes Gutenberg-University Mainz
    B.1.3.4CountryGermany
    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 supportUniversitätsmedizin der Johannes Gutenberg-University Mainz
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationI. Medizinische Klinik und Poliklinik Johannes-Gutenberg-Universität Mainz
    B.5.2Functional name of contact pointPD Dr. Markus Moehler
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstraße 11
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number004906131175712
    B.5.5Fax number004906131176410
    B.5.6E-mailmoehler@mail.uni-mainz.de
    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 12.5 mg Hartkapseln
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd., Ramsgate Road, Sandwich, Kent CT13 9NJ, Vereinigtes Königreich
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    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.3.9.1CAS number 341031-54-7
    D.3.9.3Other descriptive nameSUNITINIB MALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    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
    Chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus
    E.1.1.1Medical condition in easily understood language
    The advanced cancer of lower esophagus and stomach has not responded satisfactorily to the previous chemotherapy
    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 LLT
    E.1.2Classification code 10001173
    E.1.2Term Adenocarcinoma of esophagus
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007474
    E.1.2Term Carcinoma stomach
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the progression-free survival (PFS) according to RECIST 1.1 in patients with chemo-refractory advanced or metastatic adenocarcinoma of stomach or lower esophagus and FOLFIRI-based chemotherapy.
    E.2.2Secondary objectives of the trial
    • Objective response rate (CR + PR)
    • Tumor control rate
    • Duration of disease stabilisation
    • 1-year overall survival
    • Overall survival
    • Safety and tolerability of placebo-controlled combination therapy in comparison to standard second line therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated informed consent before the start of specific protocol procedures;
    • Histological proven gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction or lower esophagus;
    • Failure of any prior chemotherapy (docetaxel and/or platinum-based chemotherapy); but patient has not previously received FOLFIRI treatment;
    • Measurable metastatic disease according to the RECIST 1.1 criteria. If locally recurrent disease, it must be associated with at least one measurable lymph node (> 20 mm by CT scan or > 10 mm with spiral CT);
    • Age: ≥ 18 years;
    • Karnofsky index 100 – 70 %
    • Life expectancy > 12 weeks;
    • Adequate hematological, hepatic and renal functions: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; creatinine ≤ 2 x UNL; total bilirubin ≤ 3 x UNL, AST (SGOT) and ALAT (SGPT) ≤ 3 x UNL; in case of liver metastases: total bilirubin ≤ 6 x UNL, AST (SGOT) and ALAT (SGPT) ≤ 6 x UNL;
    • At least 3 weeks from previous docetaxel– and/or platinum-based chemotherapy;
    • Recovery from hematological side effects (CTC grade < 1) and non-hematological side effects (CTC grade ≤ 1) of any prior therapy (except oxaliplatine induced neuropathy CTC grade ≤ 2);
    • Able to comply with scheduled assessments and with management of toxicity;
    E.4Principal exclusion criteria
    • History of another primary malignancy ≤3 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix;
    • Any prior palliative radiotherapy of the target lesions;
    • Concurrent treatment with any other medicinal anti-cancer therapy;
    • Prior treatment with a VEGF, VEGFR or RTK inhibitor, or prior enrolment on this study (some inhibitors may be allowed after obtaining Sponsor approval);
    • Known allergic/hypersensitivity reaction to any of the components of the treatment;
    • Treatment with potent CYP3A4 inhibitor within 7 days of Sunitinib/placebo dosing or with potent CYP3A4 inducer within 12 days of Sunitinib/placebo dosing; except dexamethasone for the prevention of chemotherapy induced emesis;
    • Other serious illness or medical conditions within the last 12 months prior to study drug administration:
    - Unstable cardiac disease despite treatment; myocardial infarction within 12 months prior to study entry; congestive heart failure NYHA grade 3 and 4;
    - Hypertension that cannot be controlled by medication (>150/100 mmHg) despite optimal medical therapy;
    - Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females;
    - History of significant neurologic or psychiatric disorders including dementia or seizures;
    - Active uncontrolled infection;
    - History of clinically significant bleeding within the past 6 months, including hemoptysis or haematuria, or underlying coagulopathy;
    - Active disseminated intravascular coagulation;
    - Cerebrovascular accident including transient ischemic attack;
    - Pulmonary embolus;
    - Bowel obstruction or chronic diarrhoea, history or presence of inflammatory enteropathy or extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis;
    - Peptic ulcer disease;
    - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment, unless affected area has been removed surgically;
    • Known deficit in DPD;
    • Hypercalcemia not controlled by bisphosphonates;
    • Contraindications to the use of atropine;
    • Pregnant or lactating women; female patients who are pregnant or lactating or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 3 months after discontinuing study treatment;
    • Known drug abuse/alcohol abuse;
    • Current, recent, or planned participation in an experimental treatment drug study other than this protocol;
    • Major surgical procedure, open biopsy or significant traumatic injury within 4 weeks before starting treatment; anticipation of need for major surgical procedure (e.g. impending bowel obstruction) during the course of the study;
    • History of other medical or psychiatric condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The response to treatment is measured by computer tomography (CT) after every cycle.
    E.5.2Secondary end point(s)
    • Objective response rate (CR + PR) according to RECIST 1.1
    • 1-year survival
    • Safety (according to NCI-CTCAE V4.0) and tolerability
    • Progression-free survival rate: The time from first intake/dose of trial medication to first documentation of objective tumour progression or to death due to any cause, whichever occurs first.
    • 1-year survival: rate of subjects surviving for at least one year after first intake/dose of trial medication.
    • Overall survival: the time between first applications of trial medication to date of death due to any cause.

    E.5.2.1Timepoint(s) of evaluation of this end point
    The response to treatment is measured by computer tomography (CT) after every cycle.
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned15
    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 Information not present in EudraCT
    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
    Defined in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months39
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state90
    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)
    see 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 Decision2009-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-01
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