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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-002826-70
    Sponsor's Protocol Code Number:A3671008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-002826-70
    A.3Full title of the trial
    Phase 2, open label, single arm study to evaluate the efficacy, safety, tolerability and pharmacokinetics of Ticilimumab in patients with advanced refractory and/or relapsed melanoma
    Estudio de fase II, abierto, de un sólo brazo para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de ticilimumab en pacientes con melanoma avanzado refractario y/o recurrrente
    A.4.1Sponsor's protocol code numberA3671008
    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 SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 Information not present in EudraCT
    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 nameA3671008
    D.3.2Product code CP-675, 206
    D.3.4Pharmaceutical form Solution for injection
    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 INNtacilimumab
    D.3.9.1CAS number 745013-59-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level VTc
    E.1.2Classification code 10025650
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the anti-tumor efficacy, as determined by objective response rate, ofintravenous ticilimumab administered at a dose of 15 mg/kg every 90 days to patientswith relapsed or refractory advanced melanoma.
    E.2.2Secondary objectives of the trial
    To assess additional evidence of anti-tumor activity as measured by best on-study response rate, durable response rate, duration of response, progression-free survivial, andoverall survival.
    To further characterize the safety profile and tolerability of ticilimumab in these settings.
    To further characterize the pharmacokinetics (PK) of ticilimumab.
    To identify any human antihuman antibody (HAHA) response to ticilimumab.
    To explore whether the cytotoxic T lymphocyte-associated antigen 4 (CTLA4),FcgammaRIIa and IgG2a genotypes influence the safety, immune response and orefficacy of patients treated with ticilimumab.
    To explore the relationships between clinical response (efficacy or toxicity) and tumor orblood genomics.
    To explore health-related quality-of-life outcomes (HQoL) and satisfaction with treatment.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible for the study, patients must satisfy all of the following criteria:
    1. Histologically confirmed melanoma that is surgically incurable and either:
    Stage III melanoma (AJCC 6th edition) including locally relapsed, in-transit lesions or draining nodes OR
    Stage IV melanoma (M1a, M1b or M1c).
    2. Prior treatment must include one, and not more than one, systemic therapy for the treatment of metastatic disease. Prior (first-line) systemic regimen for the treatment of metastatic melanoma must contain interleukin-2, dacarbazine and/or temozolamide or interfero-alfa. Patient must have received at least one cycle at full dose.
    3. Documented disease progression after the last dose of prior therapy. Previously treated patients will include patients whose disease progressed during previous treatment (refractory), recurred following previous treatment (relapsed) or patients who could not tolerate previous treatment due to unacceptable toxicity and subsequently progressed.
    4. A minimum of one measurable lesion according to Response Evaluation Criteria in SolidTumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter more than equal to 2.0 cm using conventional techniques or diameter ≥1.0 cm with spiral CT scan. If the measurable disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology. Clinically detected lesions will only be considered measurable when they are superficial (eg, skin nodules) and the longest diameter is ≥ 2 cm. Palpable lymph nodes ≥ 2.0 cm should be demonstrable by CT scan. Tumor lesions that are situated in a previously irradiated area will be considered measurable if progression is documented following completion of radiation therapy.
    NOTE: As a point of clarification for this study, skin lesion(s) selected as target lesionswill be accurately measured, and longest diameter will be at least 1.0 cm. Care should be exercised during biopsy procedures to prevent the alteration of the longest diameter of the selected skin lesion(s). Documentation by color photography, including a ruler to document the size of the target lesion(s), is required.
    5. ECOG performance status (PS) 0 or 1.
    6. Age ≥18 years.
    7. Adequate bone marrow, hepatic, and renal function determined within 14 days prior to enrollment, defined as:
    Absolute neutrophil count ≥1.5 x 9 to the power of 10 cells/L
    Platelets ≥100 x 9 to the power of 10/L
    Hemoglobin ≥10 g/dL
    Aspartate and alanine aminotransferases (AST, ALT) less than equal to 2.5 x ULN (less than equal to 5 x ULN, if documented liver metastases are present)
    Total bilirubin less than equal to 2 x ULN (except patients with documented Gilbert’s syndrome)
    Serum creatinine less than equal to 2 mg/dL or calculated creatine clearance more than equal to 60 mL/min.
    Serum lactic acid dehyrdrogenase (LDH) less than equal to 2 x ULN
    9. Patients must have recovered from all prior treatment-related toxicities, to baseline status, or to NCI CTCAE (v 3.0) Grade of 0 or 1, except for toxicities not considered a safety risk such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy. Post-surgical pain shall not be considered a basis for exclusion.
    10. Must be willing and able to provide written informed consent.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Diagnosed with melanoma of ocular origin.
    2. Received treatment for cancer, including immunotherapy, within one month prior to enrollment (dosing).
    3. Received any prior vaccine therapy for the treatment of melanoma.
    4. Received any prior CTLA4-inhibiting agent.
    5. Previously randomized to Pfizer study A3671009: A Phase 3, Open Label, RandomizedComparative Study of Ticilimumab and Either Dacarbazine or Temazolamide in Patients with Advanced Melanoma.
    6. History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.). Active vitiligo or a history of vitiligo will not be a basis for exclusion.
    7. History of, or clinically apparent hepatitis B or hepatitis C.
    8. History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin.
    9. History of uveitis or melanoma-associated retinopathy.
    10. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (Note: inhaled or topical steroids in standard doses are allowed.)
    11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
    12. Any serious, uncontrolled medical disorder or active infection which would impair their ability to receive study treatment.
    13. Brain metastases. Radiological documentation of absence of brain metastases at screening is required for all patients.
    E.5 End points
    E.5.1Primary end point(s)
    Best Overall Response (BR) based on Response Evaluation Criteria inSolid Tumors (RECIST), and defined as the proportion of patientswith a confirmed complete (CR) or partial response (PR) relative to thetotal number of evaluable patients.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    - heath-related quality of life outcomes (HQoL) and antihuman antibody to ticilimumab
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 215
    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 Decision2005-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-18
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