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    Summary
    EudraCT Number:2010-018850-11
    Sponsor's Protocol Code Number:MHH_CCA_AG54
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-22
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-018850-11
    A.3Full title of the trial
    Panitumumab in combination with cisplatin/gemcitabine chemotherapy in patients with cholangiocarcinomas - a randomized clinical phase II study - PiCCA Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Panitumumab in combination with cisplatin/gemcitabine chemotherapy in patients with bile duct cancer - a randomized clinical phase II study - PiCCA Study
    A.3.2Name or abbreviated title of the trial where available
    PiCCA
    A.4.1Sponsor's protocol code numberMHH_CCA_AG54
    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 SponsorMedizinische Hochschule Hannover (MHH)
    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 supportAMGEN GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiSP GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressKarl-Benz-Str. 1
    B.5.3.2Town/ cityLangenfeld
    B.5.3.3Post code40764
    B.5.3.4CountryGermany
    B.5.4Telephone number492173853130
    B.5.5Fax number4921738531311
    B.5.6E-mailinfo@wisp.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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B. V.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.9.4EV Substance CodeSUB25390
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    cholangiocarcinoma / gall bladder carcinoma
    E.1.1.1Medical condition in easily understood language
    patients with non removable cancer of the bile ducts / gall bladder carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10017620
    E.1.2Term Gallbladder carcinoma
    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 15.0
    E.1.2Level LLT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    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
    To determine the efficacy of panitumumab plus the cisplatin/gemcitabine combination chemotherapy in k-ras wildtype in patients with cholangiocarcinoma / gallbladder carcinoma, compared to the historical data for the same chemotherapy, which are verified by a randomised control group without the antibody.
    E.2.2Secondary objectives of the trial
    Response rate (RR) within 48 weeks of treatment, progression-free survival (PFS), overall survival (OS), safety: explorative evaluation in relation to the findings in the reference arm with respect to efficacy and toxicity, translational research: correlation of tumor response with KRAS, PTEn and B-Raf alterations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed and dated informed consent before the start of specific protocol procedures.
    Histologically or cytologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma
    Presence of at least one measurable site of disease following RECIST V. 1.1 criteria
    Wild-type KRAS status as assessed by standardized PCR
    Unresectable, locally advanced or metastatic disease
    Age > 18 years.
    ECOG Performance Status of 0 or 1
    Life expectancy of at least 12 weeks.
    Adequate bone marrow, liver (with stenting for any obstruction, if required) and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
    -Hemoglobin > 10.0 g/dl
    -Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3
    -Platelet count >= 100.000/mm³
    -Total bilirubin < 5,0 times the upper limit of normal
    -ALT and AST < 3 x upper limit of normal
    -Alkaline phosphatase < 5 x ULN
    -PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
    -Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min.
    -Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal
    The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
    Negative pregnancy test performed within 7 days of the start of treatment, and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
    E.4Principal exclusion criteria
    KRAS mutation
    Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
    History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
    History of HIV infection or chronic hepatitis B
    Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
    Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
    Symptomatic or known brain metastases. A scan to confirm the absence of brain metastases is not required.
    Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    History of organ allograft
    Patients with evidence or history of bleeding diathesis
    Patients undergoing renal dialysis
    Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix
    Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    Excluded therapies and medications, previous and concomitant:
    No prior anti-cancer chemotherapy, radiotherapy (excluding palliative radiotherapy administered more than 4 weeks prior to study entry), endocrine or immunotherapy.
    Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    Major surgery within 4 weeks of starting the study and patients must have recovered from effects of major surgery
    Prior anti-EGFR therapy
    Autologous bone marrow transplant or stem cell rescue within 4 months of study
    Breast-feeding patients
    Substance abuse, medical, psychological or social conditions that may interfere with the patient’s understanding of the informed consent procedure, participation in the study or evaluation of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to determine the efficacy of panitumumab plus cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract cancer patients without systemic pre-treatment, compared to the historical data for standard CisGem chemotherapy, which are verified by a randomised control group without the antibody. The primary endpoint is the progression-free survival rate after 6 months, based on the ITT population.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after trial inclusion
    E.5.2Secondary end point(s)
    Secondary endpoints to be analyzed in both study arms (including exploratory comparisons) are:
    Tumor response according to RECIST criteria within the first 48 weeks of treatment
    Progression-free survival (PFS)
    Overall survival (OS)
    Toxicity/safety
    Translational: assessment/correlation of tumor response with KRAS (mandatory), EGFR, PTEN and BRAF (all 3 optional in the scope of the translational research) alterations in cholangiocarcinomas and gallbladder cancer.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor response within the first 48 weeks of treatment
    PFS, OS on event
    Toxicity/safety after end of therapy
    Translational correlation on response evaluation

    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard therapy with Cisplatin and Gemcitabine
    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 concerned13
    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 No
    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
    CF. section 5.11 of the 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 months0
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state92
    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)
    Cf. section 6.4 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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-15
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