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    Summary
    EudraCT Number:2007-004102-27
    Sponsor's Protocol Code Number:SCI-RP-Pan-P2-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-01-09
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-004102-27
    A.3Full title of the trial
    A Randomized, Double Blind, Placebo Controlled, Phase II Study Evaluating the Efficacy and Safety of RP101 in Combination with Gemcitabine Administered as First-Line Treatment to Subjects with Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
    A.4.1Sponsor's protocol code numberSCI-RP-Pan-P2-001
    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 SponsorSciClone Pharmaceuticals, Inc.
    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 Helpin RP101 (BVDU)
    D.2.1.1.2Name of the Marketing Authorisation holderBerlin-Chemie
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameBrivudin (BVDU)
    D.3.2Product code RP101
    D.3.4Pharmaceutical form 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 INNBRIVUDINE
    D.3.9.1CAS number 69304478
    D.3.9.2Current sponsor codeRP101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number190
    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.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 Yes
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGemzar 200/-1000
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 95058814
    D.3.9.2Current sponsor codeGEMZAR
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 placeboTablet
    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
    metastatic pancreatic cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033605
    E.1.2Term Pancreatic cancer metastatic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinoma.
    E.2.2Secondary objectives of the trial
    - To compare progression-free survival (PFS) between the two treament arms
    - To compare the two treatment groups with respect to overall tumor response rates (ORR) which is the sum of the complete respone (CR) and partial response (PR) rates as assessed by the Response Evalulation Criteria in Solid Tumors (RECIST) in subjects with measurable disease at baseline
    - To compare the two treatment arms with respect to disease control rates (DCR) which is the sum of CR, PR and stable disease (SD) rates as assessed by RECIST in subjects with measurable disease at baseline
    - To compare the CR rates between the two treatment arms
    - To evaluate the CA 19-9 levels as a marker of disease response
    - To compare changes in ECOG performance status between the two treatment arms
    - To evaluate the safety of RP101
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 19 years of age or older
    2. Subjects with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas that is unresectable, locally advanced or metastatic
    3. ECOG performance status 0 or 1
    4. Life expectancy of at least 3 months
    5. Documentation of all sites of pancreatic cancer disease withing 28 days prior to treatment start by CT or spiral CT or MRI scan of chest, abdomen, brain (only if clinical suspicion of metastasis), and other scans necessary. Negative scans performed within 35 days of randomization do not need to be repeated
    6. Adequate hematological, renal, and hepatic function within 14 days prior to treatment start defined as follows:
    -Hemoglobin (HGB) ≥ 9.0 gm/dL (prior transfusion and/or support with erythropoietin-based products is acceptable)
    -Absolute granulocyte count ≥ 1.5 x 109/L (1500 cells/mm3) unsupported for 1 week by growth factors
    -Platelet count ≥ 100 x 109/L (100,000/mm3) non-platelet transfusion dependent
    -Serum creatinine < 1.5 times the upper limit of normal
    -Total bilirubin < 2.0 times the upper limit of normal
    -ALT (SGPT) < 2.0 times the upper limit of normal and/or AST (SGOT) < 2.0 times the upper limit of normal. If clearly attributable to liver metastasis, ALT and/or AST < 5.0 times the upper limit of normal is permitted
    7. Capability of understanding the objectives of the study and giving written informed consent
    8. Willingness and ability to comply with the study protocol for the duration of the study
    9. Capability to have sufficient oral caloric and fluid intake and to take oral study medications
    10. If subject is female and of child bearing potential she must have a negative β-HCG urine test within 72 hours prior to receiving treatment. Being of child bearing potential is defined as any female subject who does not meet at least one of the following criteria: a) has undergone bilateral salpingo-oophorectomy and/or hysterectomy; b) is greater than age 50 years and has not had a menstrual period for at least 24 months
    11. All potentially fertile subjects, both female and male, must practice a medically approved method of contraception or agree to abstinence for the duration of participation in the active treatment phase of the study and for a period of 4 weeks after the last administration of either study drug
    E.4Principal exclusion criteria
    1. Prior history of other malignant tumors, except non-melanoma skin cancer or in situ cervical carcinoma curatively excised. Subject may be included if disease-free of cancers other than pancreatic cancer for 5 years
    2. Major surgery within 2 weeks prior to treatment start
    3. Any prior cytotoxic chemotherapy other than 5-FU (+/- folinic acid) or gemcitabine given concurrently with radiation treatment as a “radiosensitizer”. 5-FU must not have been given within 21 days prior to randomization.
    4. Radiation treatment within 4 weeks of treatment start. Prior radiation treatment for management of local disease is allowed, provided that local disease progression or progression by new measurable metastasis outside of the radiation portal is documented by imaging procedure, all toxicities resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to treatment start.
    5. Uncontrolled cardiac atrial or ventricular arrhythmias (New York Heart Association (NYHA) congestive heart failure ≥ class 2; uncontrolled hypertension; pulmonary embolism or cerebrovascular accident (CVA) within 6 months
    6. Neurologic: symptomatic motor or sensory neurotoxicity grade ≥ 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC)
    7. Central nervous system metastasis
    8. Psychiatric disabilities, seizures or central nervous system disorders thought to be clinically significant in the opinion of the Investigator that could interfere with informed consent or compliance with the protocol
    9. Active bleeding Grade ≥ 2 of NCI-CTC
    10. Serious (Grade 3-4 of NCI-CTC) active infections at time of treatment start
    11. Subjects with known allergies or intolerance to RP101 or similar compounds
    12. Subjects with known allergies or intolerance to gemcitabine
    13. Participation in any investigational drug study with investigational drug exposure within 4 weeks prior to treatment start
    14. Pregnant or breast feeding women
    15. Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, such as uncontrolled inflammatory GI diseases (eg, Crohn’s disease, ulcerative colitis) or postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency or requires IV hyperalimentation (however, use of pancreatic enzyme supplementation is allowed provided that the above criteria are not met) resulting in an inability to take oral medication
    16. Known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis
    17. Any condition which in the judgment of the Investigator would place the subject at undue risk or interfere with the results of the study (eg, low medical risks because of non-malignant organ or systemic disease, or secondary effects of cancer)
    18. Uncontrolled cancer pain.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be overall survival defined as the time from randomization to death from any cause or last contact if alive
    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 Yes
    E.8.1.7.1Other trial design description
    Gemcitabine will be used as background treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gemcitabine will be used as background treatment
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    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 months8
    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 months8
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 153
    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)
    Subjects who complete 6 cycles of therapy and who, 1) are non-progressors; and 2) have a level of treatment-related toxicity and overall medical status that, in the judgment of the PI, would permit additional therapy, may be eligible to receive additional cycles of the assigned therapy pending confirmation by SciClone Pharmaceuticals, Inc. All subjects will be followed monthly until death or loss to follow-up to monitor survival, disease status and any subsequent treatment.
    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 Decision2008-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-10-02
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