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    Summary
    EudraCT Number:2006-004824-35
    Sponsor's Protocol Code Number:309846
    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:2007-02-12
    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 number2006-004824-35
    A.3Full title of the trial
    A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum
    A.3.2Name or abbreviated title of the trial where available
    Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRC
    A.4.1Sponsor's protocol code number309846
    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 SponsorSchering AG
    B.1.3.4CountryGermany
    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 No
    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 namePTK787/ZK 222584
    D.3.2Product code SH T00268C
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNVatalanib succinate
    D.3.9.1CAS number 212142-18-2
    D.3.9.2Current sponsor codeZK 222584
    D.3.9.3Other descriptive namePynasunate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number335
    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 placeboFilm-coated tablet
    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
    advanced, previously treated metastatic adenocarcinoma of the colon or rectum
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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 compare the pharmacodynamic activity of PTK787/ ZK 222584 by dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) at trough levels in once daily (o.d.) versus twice daily (b.i.d.) treatment arms.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the efficacy, safety, tolerability, pharmacokinetics, and biomarker activity of o.d. versus b.i.d. administration of PTK787/ ZK 222584 monotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent obtained in accordance to local and institutional guidelines
    2. Male or female patients aged ≥ 18 years
    3. Histologically confirmed metastatic adenocarcinoma of the colon or rectum
    4. At least one line of prior standard chemotherapy for metastatic disease; standard systemic therapy for metastatic disease includes fluoropyrimidines, oxaliplatin and irinotecan
    5. Measurable lesion(s) as per the modRECIST criteria
    6. At least 1 measurable liver lesion with the size of at least 3 cm for DCE-MRI evaluation
    7. WHO Performance status 0 to 2
    8. Laboratory values obtained within the last 2 weeks before randomization:
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 times ULN
    • Serum bilirubin ≤ 1.5 times ULN
    • Aspartate aminotransaminase (AST/SGOT) and alanine aminotransaminase (ALT/SGPT) ≤ 3.0 times ULN (≤ 5times ULN, if liver metastases)
    • Urine negative for proteinuria based on dip stick reading
    or, if dip stick result is ≥ '+1', then 24 hour urine collection with total urinary protein value ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min
    9. Life expectancy ≥ 12 weeks
    10. Negative pregnancy test not longer than 48 hours before administration of the study treatment for females of childbearing potential
    E.4Principal exclusion criteria
    1. Full-field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization; patients must have recovered from all therapy-related toxicities
    2. Chemotherapy ≤ 3 weeks prior to randomization; patients must have recovered from all therapy-related toxicities (grade 1 neuropathy after oxaliplatin containing chemotherapy is allowed)
    3. Biologic or immunotherapy ≤ 6 weeks prior to randomization; patients must have recovered from all therapy-related toxicities
    4. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 6 weeks prior to randomization
    5. Concomitant use of proton pump inhibitors and H2-antagonists (please refer also to section 6.1). The use of antacids taken at least 2 hours before or after the study drug is allowed.
    6. Major surgery ≤ 4 weeks prior to randomization; minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is not considered as major or a minor surgery. Patients must have recovered from all surgery-related toxicities.
    7. Pleural effusion or ascites that causes ≥ CTC grade 2 dyspnoea
    8. History or clinical signs of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
    9. Concurrent severe and / or uncontrolled medical disease (i.e., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months, poorly controlled hypertension, history of labile hypertension, history of poor compliance with antihypertensive regimen, chronic renal disease, chronic liver disease, confirmed diagnosis of human immunodeficiency virus (HIV) infection or active uncontrolled infection) or significant neurologic or psychiatric disorder, which could compromise participation in the study
    10. History of another primary malignancy ≤ 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ
    11. Long QT syndrome or baseline 12-lead electrocardiogram (ECG) QTcF greater than 450 msec for males and 470 msec for females
    12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK/ZK (i.e., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, inability to swallow the tablets)
    13. Pregnant or breastfeeding females
    14. Subjects of both sexes unwilling or unable to use a required barrier method of contraception during participation
    15. Unwillingness or inability to comply with the study protocol
    16. Previous assignment to treatment during this study
    17. Presence of any condition excluding tumor scans by (DCE-) MRI (Attachment 2) or CT
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the number of patients with at least 40% reduction in Ktrans from baseline to Day 28.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    stratified
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    od versus bid blinded by placebo
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    In compliance with EU regulations, the end of study is defined as the last patient’s last visit (LPLV).
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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.1.3Elderly (>=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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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 Decision2007-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-28
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