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    Summary
    EudraCT Number:2012-002378-30
    Sponsor's Protocol Code Number:CPN710102
    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:2012-06-29
    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 number2012-002378-30
    A.3Full title of the trial
    Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma
    CAP7.1 in einer Phase II Studie zur Behandlung von Patienten mit therapie-refraktären Tumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma
    CAP7.1 in einer Phase II Studie zur Behandlung von Patienten mit therapie-refraktären Tumoren
    A.3.2Name or abbreviated title of the trial where available
    PIITCAP
    A.4.1Sponsor's protocol code numberCPN710102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02094560
    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 SponsorCellAct Pharma GmbH
    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 organisationCellAct Pharma GmbH
    B.5.2Functional name of contact pointNalân Utku
    B.5.3 Address:
    B.5.3.1Street AddressLeopoldstr. 30
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80802
    B.5.3.4CountryGermany
    B.5.4Telephone number+4923197426350
    B.5.5Fax number+4989414144011
    B.5.6E-mailn.utku@cellact.eu
    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 nameCAP 7.1
    D.3.2Product code CAP 7.1
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Therapy refractory none small cell lung Cancer (NSCLC), small cell lung Cancer (SCLC) and Biliary carcinoma
    E.1.1.1Medical condition in easily understood language
    Lung and Gallbladder Tumors where no further treatment option available.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the antitumor activity of CAP7.1 based on the observed objective rersponse rate and rate of disease stabilization using Recist.
    E.2.2Secondary objectives of the trial
    To assess the following efficacy, safety and pharmacokinetics parameters:


    Duration of response and disease stabilization
    Rate of PD
    Progressive free survival (PFS),
    Overall survival (OS)
    Safety of CAP7.1 C max, Tmax, t1/2, AUC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ➢ Age ≥ 18 years
    ➢ ECOG Performance Status of 0-2
    ➢ Life expectancy of at least 8 weeks
    ➢ Adequate bone marrow and organ function including:
    ➢ Hemoglobin ≥ 9.0 g/dL
    ➢ Absolute neutrophil count (ANC) ≥ 1,500/mm3
    ➢ Platelet count ≥ 100,000/mm3
    ➢ Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
    ➢ ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement)
    ➢ PT-INR and PTT < 1.5 x ULN
    ➢ Creatinine clearance (CrCl) >50 mL/min (according to modified Cockcroft-Gault criteria: CrCl = Wt (kg) × (140-age)/72 × Creatinine level, male x 1, female × 0.85)
    ➢ Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy.
    ➢ Patients with a history of brain metastasis are eligible provided they have been adequately treated with surgery, radiotherapy and steroids, and are presently stable without evidence of disease. These patients may be receiving low dose glucocorticoids provided the dose has been stable for at least two weeks prior to starting study medication
    ➢ Medically controlled, negative pregnancy test in all women except those who were surgically sterile or at least one year postmenopausal
    Female patients of child-bearing potential are eligible, if they agree to use a highly effective method of birth control throughout the study and for at least 4 weeks after stopping treatment
    Male patients with partners of child-bearing potential are eligible, if they agree to use barrier contraception during the trial and for 6 months after stopping study drug, unless surgically sterile.
    ➢ Written informed consent according to ICH-GCP, and national/local regulations
    ➢ High probability of a good compliance and orderly completion of the study

    Additional inclusion criteria specific for NSCLC
    ➢ Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
    ➢ At least one measurable lesion according to RECIST criteria version 1.1.
    ➢ Documented disease progression (RECIST) after last therapy
    ➢ Prior therapy with two lines of chemotherapy for advanced disease one of which should have consisted of a platin based combination regimen
    ➢ Patients with tumors known to have mutated EGFR must have received one line of EGFR inhibitor therapy in addition to one only line of chemotherapy for advanced disease
    ➢ Patients whose tumors are known to have an ALK translocation or ROS1 activation must have received one line of therapy with an ALK inhibitor in addition to one only line of chemotherapy for advanced disease
    ➢ Patients may have received an additional regimen as neo/adjuvant chemotherapy as part of treatment for early disease
    ➢ Patients may have received prior maintenance therapy
    ➢ Prior Radiotherapy is acceptable provided it involved <25% of red bone marrow. At least one week should have elapsed from completion of prior radiotherapy and the patient must have recovered from acute toxic effects. If the measurable lesions(s) are in the field of radiotherapy at least 6 weeks should have elapsed from completion or radiotherapy, and progression must be confirmed radiologically
    ➢ Radiotherapy for isolated (bone) lesions is permitted during the study
    Additional inclusion criteria specific for SCLC
    ➢ Histologically- or cytologically-confirmed, limited and extensive SCLC disease, with documented progression.
    ➢ At least one measurable lesion according to RECIST criteria version 1.1 situated in a non-previously irradiated area
    ➢ One line of prior double chemotherapy combination including adequate doses of a platinum compound and etoposide, and having progressed during chemotherapy or within the first 6 months from completion of chemotherapy.
    ➢ Prior Radiotherapy is acceptable provided it involved <25% of red bone marrow and that the patient has recovered from any radiotherapy related acute toxicities
    Additional inclusion criteria specific for Biliary Cancer
    ➢ Histologically or cytologically confirmed diagnosis of biliary tract cancer
    ➢ At least one measurable lesion according to RECIST version 1.1.
    ➢ Documented disease progression (RECIST) after one chemotherapy line including cisplatin. The patients may have received also prior neo/adjuvant chemotherapy
    ➢ Patients may also have received one line of molecular targeted therapy (single aqent or combination of targeted agents) and progressed while on therapy or after completion
    ➢ Prior Radiotherapy is acceptable provided it involved <25% of red bone marrow
    ➢ Total bilirubin ≤ 5 times the upper limit of normal (ULN)
    E.4Principal exclusion criteria
    NSCLC, SCLC and Biliary Carcinomas
    ➢ Serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results.
    ➢ Patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (HIV) or with chronic hepatitis B or hepatitis C virus infection are not eligible for the study
    ➢ Other psychological or social conditions which in the investigator’s opinion would not make the patient a good candidate for the clinical trial
    ➢ Pregnancy or breast-feeding
    ➢ Participation in another clinical trial within 30 days prior to the screening visit
    ➢ Patients who are committed to an institution according to an order of court or an official directive
    ➢ Receiving other anti-cancer therapies
    ➢ Patients who are committed to an institution according to an order of court or an official directive.
    Additional exclusion criteria for NSCLC and SCLC
    ➢ Uncontrolled pleural effusion
    ➢ Receiving other anti-cancer therapies except Bisphosphonates (or denosumab).
    Additional exclusion criteria specific for NSCLC only
    ➢ Patients eligible for EGFR therapy or ALK inhibitor therapy
    ➢ History of another malignancy which could affect compliance with the protocol or interpretation of results. Patients who have been treated with curative intent and remained disease-free for at least 3 years are generally eligible, as are patients with in situ disease treated with curative intent.
    Additional exclusion criteria specific for SCLC only
    ➢ History of another malignancy which could affect compliance with the protocol or interpretation of results. Patients who have been treated with curative intent and remained disease-free for at least 5 years are generally eligible, as are patients with in situ disease treated with curative intent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be the rate of disease control, i.e. (CR+PR+stable disease, according to RECIST)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After every second treatment cycle, frequency depending on duration.
    E.5.2Secondary end point(s)
    Duration of response and disease stabilization

    Rate of PD

    Progressive free survival (PFS),

    Overall survival (OS)

    Safety of CAP7.1 C max, Tmax, t1/2, AUC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of response after every second treatment cycle, frequency of evaluation is depend on disease duration; safety evaluation on weekly bases; Pk evaluation pre and after infusion in Cycle one and two.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial6
    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 concerned18
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Follow-up for safety: 30 days or longer if needed

    Follow-up for survival: for 6 months after therapy discontinuation or until half the patients have died, which ever occurs earlier.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) No
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    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)
    Patients will be offered further treatment with CAP7.1 in case of stable disease until progression. However, treatment options are based on individual patient condition and decision of the investigators.
    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 Decision2012-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-10
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