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    Summary
    EudraCT Number:2006-004956-19
    Sponsor's Protocol Code Number:06762004
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-02
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2006-004956-19
    A.3Full title of the trial
    A randomized, open-label, multi-center, phase II/III study on treatment with ABR-217620 combined with IFN-α vs. IFN-α alone in patients with advanced renal cell carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II/III study on treatment with ABR-217620 combined with IFN-α vs. IFN-α alone in patients with advanced renal cell carcinoma
    A.4.1Sponsor's protocol code number06762004
    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 SponsorActive Biotech AB
    B.1.3.4CountrySweden
    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 supportActive Biotech AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActive Biotech AB
    B.5.2Functional name of contact pointGunnel Bengtsson
    B.5.3 Address:
    B.5.3.1Street AddressBox 724
    B.5.3.2Town/ cityLund
    B.5.3.3Post code220 07
    B.5.3.4CountrySweden
    B.5.4Telephone number+46 46 19 10 00
    B.5.5Fax number+46 46 19 20 10
    B.5.6E-mailgunnel.bengtsson@activebiotech.com
    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 nameABR-217620
    D.3.2Product code ABR-217620
    D.3.4Pharmaceutical form Powder for injection
    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 INNnaptumomab estafenatox
    D.3.9.1CAS number 676258-98-3
    D.3.9.2Current sponsor codeABR-217620
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Renal Cell Carcinoma
    E.1.1.1Medical condition in easily understood language
    Renal Cell Carcinoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10038395
    E.1.2Term Renal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival
    E.2.2Secondary objectives of the trial
    • Progression free survival
    • Duration of response
    • Immunological response
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed renal cell carcinoma (clear cell and papillary types). Biopsy of a metastasis is permitted if the primary tumor is inapproachable.
    2. Metastatic or inoperable locally advanced renal cell cancer.
    3. Patient must be eligible for therapy with IFN-α.
    4. Measurable disease defined by the presence of at least one measurable lesion documented on CT scan (lesion diameter ≥ 2.0 cm measured by a standard (conventional) CT scanner or ≥ 1.0 cm measured by a spiral CT scanner).
    5. Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2).
    6. Karnofsky performance status ≥ 70.
    7. Age ≥ 18 years.
    8. Life expectancy > 3 months.
    9. Patient has the following blood counts at baseline:
    • absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • platelets ≥ 100 x 109/L
    • haemoglobin ≥ 100 g/L
    10. Patient has the following blood chemistry levels at baseline:
    • creatinine ≤ 1.5 × upper limit of normal
    • bilirubin ≤ 2 × upper limit of normal
    • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal. AST and ALT allowed ≤ 5 × upper limit of normal for patients with liver metastases.
    11. If fertile, the patient agrees to use an effective method of contraception from the screening visit through the duration of study participation (barrier method for males; hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence for females).
    12. The patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations.
    13. Patient is capable of understanding the parameters outlined in the protocol and able to sign a written informed consent form.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women are prohibited to take part in the study.
    2. A serious uncontrolled medical disorder or active infection which are either ongoing or have resolved within 2 weeks before the first dose of the study treatment and which in the opinion of the investigator would impair the patient’s ability to receive the study treatment.
    3. History of any malignancy within the past 5 years or any concurrent malignancy, with the exception of the following malignancies, which may still be included if successfully treated: non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast.
    4. History and/or signs of parenchymal brain metastases.
    5. Significant cardiac disease including: history (within the past 6 months) or current unstable angina pectoris, congestive heart failure of stage III-IV (NYHA), or myocardial infarction within the past 12 months; or patients with uncontrolled arterial hypertension.
    6. History of a stroke within the past 5 years and/or transient ischemic attack within the past 6 months.
    7. Acute illness or evidence of infection, including unexplained fever (body temperature > 100.5 degrees F or 38.1degrees C) within 2 weeks prior to start of treatment.
    8. Treatment with beta-blockers, excluding topical therapy for glaucoma, within 5 days prior to the start of the study treatment and during the 4 day ABR-217620 treatment period.
    9. Treatment with systemic corticosteroids within 2 weeks prior to the start of treatment or the patient will likely require such treatment throughout the study.
    10. Active autoimmune disease requiring therapy or any history of systemic lupus erythematosis or rheumatoid arthritis.
    11. Treatment with biological response modifiers within 3 weeks of the first dose of the investigational products and up to the End-of-Study visit.
    12. Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host).
    13. Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or the known virus carrying. Patients who recovered from Hepatitis A are allowed to enter the study.
    14. Treatment with anticoagulants within 2 weeks prior to the start of treatment, except when used to maintain the patency of a central or peripheral venous line. If a patient requires anticoagulants, his eligibility should be discussed with the Medical Monitor prior to enrollment.
    15. Radiotherapy less than 4 weeks before the start of treatment. The patient should fully recover from the side effects of radiotherapy to start the study treatment.
    16. Major surgery or tumor embolization less than 4 weeks before the start of treatment. The patient should fully recover after the surgery to start the study treatment.
    17. Previous history of exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins.
    18. Patients currently on renal dialysis treatment.
    19. Known allergy or hypersensitivity to aminoglycosides and kanamycin.
    20. Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-α or IL-2 or any chemotherapy) with the exception of sunitinib or other oral antiangiogenic therapy.
    21. Participation in any other study involving investigational drugs for treatment of RCC within the last 6 weeks. The patients must not participate in any other clinical trial while on this trial (with the exception of off-drug follow-up).

    E.5 End points
    E.5.1Primary end point(s)
    • Time to death
    E.5.1.1Timepoint(s) of evaluation of this end point
    Durationof response is defined as the time from first objective status assessment of CR/PR to the first time disease progression or death is documented
    E.5.2Secondary end point(s)
    •Progression free survival time
    • Objective tumor response rate
    • Best overall response
    • Duration of response
    • Changes in Sum of Target Lesions
    • Immunological response to treatment in patients receiving combination therapy of
    ABR-217620 and IFN-α
    • Vital signs and physical measurements (body temperature, blood pressure, heart rate,
    weight and Karnofsky performance status)
    • Adverse event rate
    • Laboratory safety assessments
    • Pharmacokinetic parameters of ABR-217620
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor response will be assessed on Week 13 and 25 and then every 12 weeks until the patient’s disease progression or initiation of other systemic anti-tumor therapy
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Bulgaria
    Norway
    Romania
    Russian Federation
    Ukraine
    United Kingdom
    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
    LAST PATIENT LAST VISIT
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 424
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 524
    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)
    none
    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 Decision2007-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
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