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    Summary
    EudraCT Number:2005-000524-16
    Sponsor's Protocol Code Number:A6181054
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-11-11
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2005-000524-16
    A.3Full title of the trial
    AN OPEN LABEL INTERNATIONAL MULTI-CENTER PHASE 2 ACTIVITY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH ADVANCED / METASTATIC GASTRIC CANCER PROGRESSING OR RECURRING AFTER ONE PRIOR CHEMOTHERAPY
    A.4.1Sponsor's protocol code numberA6181054
    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 SponsorLaboratorios Pfizer, Lda
    B.1.3.4CountryPortugal
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267
    D.3 Description of the IMP
    D.3.2Product code SU011248 L-Malate Salt
    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.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267
    D.3 Description of the IMP
    D.3.2Product code SU011248 L-Malate Salt
    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.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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.IMP: 3
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267
    D.3 Description of the IMP
    D.3.2Product code SU011248 L-Malate Salt
    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.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (i.e. an adenocarcinoma with >50% extension in the stomach). Patients must present with stage IV disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLY
    E.1.2Classification code 10017758
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the antitumor activity of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients with advanced / metastatic gastric cancer, after failure of one prior chemotherapy regimen for advanced / metastatic disease.
    E.2.2Secondary objectives of the trial
    • To assess measures of clinical benefit and duration of tumor control
    • To evaluate the safety and tolerability of SU011248
    • To explore the effects of SU011248 on patient reported outcomes of health related
    quality of life (HRQOL) and gastric cancer specific symptoms.
    • To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to
    correlate these plasma concentrations with activity and safety parameters
    • To explore the correlations of cancer biomarkers with cancer- and treatment-related outcomes.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or
    gastroesophageal junction adenocarcinoma (i.e. an adenocarcinoma with >50%
    extension in the stomach).
    2. Patients must present with stage IV disease not amenable to surgery, radiation, or combined modality therapy with curative intent. Patients previously undergoing local treatment (surgery and/or radiation) must have subsequently progressed or recurred.
    3. Patients must present with disease progression or recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose >/= 4 weeks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred > 6 months after adjuvant therapy completion.
    4. Resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, or prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade 1.
    5. Measurable disease according to RECIST.
    6. Male or female, 18 years of age or older.
    7. ECOG performance status minor than /equal to 1.
    8. Adequate organ function as defined by the following criteria:
    • Absolute neutrophil count (ANC) major than/equal to 1,500/microL
    • Platelets major than/equal 100,000/microL
    • Hemoglobin major than/equal 9.0 g/dL
    • Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase) [SGPT] less than/equal to 2.5 x upper limit of normal (ULN), less than/equal to 5 x ULN if there is liver involvement secondary to tumor.
    • Total serum bilirubin less than/equal to 1.5 mg/dL (less than/equal to 2.2
    mg/dL in presence of Gilbert’s disease) regardless of liver involvement
    secondary to tumor.
    • Prothrombin time (PT) less than/equal to 1.5 x ULN
    • Serum creatinine less than/equal to 1.5 x ULN.
    9. Life-expectancy of more than/equal to 3 months.
    10. Signed and dated informed consent document indicating that the patient
    (or legally acceptable representative) has been informed of all pertinent
    aspects of the trial prior to enrollment.
    11. Willingness and ability to comply with scheduled visits, treatment plans,
    laboratory tests, and other study procedures.

    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. More than one prior chemotherapy regimen for advanced / metastatic disease.
    2. Major surgery or radiation therapy <4 weeks of starting the study treatment.
    Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is
    at least one measurable lesion that has not been irradiated.
    3. Prior radiation therapy to >25% of the bone marrow.
    4. Presence of clinically relevant ascites (i.e. requiring paracentesis) and/or major
    than/equal to NCI CTCAE Grade 2 weight loss.
    5. NCI CTCAE Grade 3 hemorrhage <4 weeks of starting study treatment.
    6. Inability to swallow oral medications, or presence of active inflammatory bowel
    disease, partial or complete bowel obstruction or chronic diarrhea.
    7. Known brain metastases, or spinal cord compression, or carcinomatous meningitis
    (baseline CT or magnetic resonance imaging [MRI] scan of the brain required only
    in case of clinical suspicion of central nervous system metastases).
    8. Diagnosis of any second malignancy within the last 3 years, except for adequately
    treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix
    uteri.
    9. 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.
    10. Ongoing cardiac dysrhythmias of NCI CTCAE grade major than /equal to 2, atrial
    fibrillation of any grade, or prolongation of the QTc interval to >450 msec for
    males or >470 msec for females.
    11. Hypertension that cannot be controlled by medications (blood pressure >150/90
    mmHg despite optimal medical therapy).
    12. Treatment with anticonvulsant agents and treatment with therapeutic doses of
    Coumadin currently or within 2 weeks prior to first day of SU011248
    administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2
    mg/day). Low molecular weight heparin is allowed.
    13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
    syndrome (AIDS)-related illness.
    14. Pregnancy or breastfeeding. All female patients with reproductive potential
    must have a negative pregnancy test (serum or urine) within the 21 days prior
    to enrollment.
    15. 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 patient
    inappropriate for entry into this study.
    16. Prior treatment on a SU011248 trial.
    17. Receipt of any investigational agent within 4 weeks prior to study entry.
    18. Current treatment on another therapeutic clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) as determined according to RECIST
    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 No
    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 Information not present in EudraCT
    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 No
    E.8.1.2Open Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Patients will receive SU011248 (Schedule 4/2) until disease progression, occurrence of unacceptable toxicity, withdrawal of patient consent, or other withdrawal criteria are met.

    .
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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 Decision2006-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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