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    Summary
    EudraCT Number:2011-002669-40
    Sponsor's Protocol Code Number:ALD518-CLIN-009
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-20
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-002669-40
    A.3Full title of the trial
    A Phase 2, Multi-center, Randomized, Double-blind,
    Placebo-controlled Clinical Trial to Evaluate the
    Safety and Efficacy of ALD518 in the Reduction of
    Oral Mucositis in Subjects With Head and Neck
    Cancer Receiving Concomitant Chemotherapy and
    Radiotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial studying the safety and effectiveness of the study drug ALD518 for treating oral mucositis in patients with head and neck cancer who are currently receiving chemotherapy and radiotherapy
    A.4.1Sponsor's protocol code numberALD518-CLIN-009
    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 SponsorAlder BioPharmaceuticals, 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 supportAlder BioPharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace, Inc.
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressGmunder Strasse 53
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81379
    B.5.3.4CountryGermany
    B.5.4Telephone number498989557180
    B.5.5Fax number49898955718100
    B.5.6E-mailregsubmissions@medpace.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 nameALD518
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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 INNALD518
    D.3.9.1CAS number 1236278-28-6
    D.3.9.2Current sponsor codeALD518
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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.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 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 nameALD518
    D.3.4Pharmaceutical form Solution for infusion in administration system
    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 INNALD518
    D.3.9.1CAS number 1236278-28-6
    D.3.9.2Current sponsor codeALD518
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion in administration system
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion in administration system
    D.8.4Route of administration of the placeboIntrauterine use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral Mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
    E.1.1.1Medical condition in easily understood language
    Swelling and or sores occurring in the mouth due to cancer treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the clinical trial is to evaluate the safety and
    efficacy of ALD518 in modifying the course of oral mucositis (OM)
    in subjects with head and neck cancer (HNC) receiving concurrent
    chemotherapy and radiotherapy (CRT).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the clinical trial are to determine the
    pharmacokinetics and pharmacodynamics of ALD518 and to evaluate
    the impact of ALD518 on health and economic outcomes in subjects
    with HNC receiving concurrent CRT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to understand and sign an Informed Consent Form (ICF) for the clinical trial approved by the Investigator’s local or a central Institutional Review Board (IRB) or Ethic Committee (EC)
    2. Have recently diagnosed (< than 6 months prior to screening visit date), pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects with a history of surgical (approximately 4-6 weeks before RT with sufficient time for post-surgical healing) management are eligible
    3. Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy at each site. Planned radiation treatment fields must include at least 2 oral sites (retromolar trigone, buccal mucosa, floor of mouth, tongue, or soft palate), with each site receiving ≥ 55 Gy
    4. Have a plan to receive a standard cisplatin or carboplatin CT regimen
    5. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    6. CRP < 80 mg/L
    7. Have adequate hematopoietic, hepatic, and renal function at the screening visit:
    Hematopoietic function
    • Hemoglobin ≥ 10 g/dL
    • Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
    • Platelet count ≥ 100 × 10^9/L
    Hepatic function
    • Total bilirubin ≤ 1.25 times the upper-normal limit (ULN)
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times the ULN
    Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site’s local laboratory. To be eligible for the clinical trial, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min or via Cockcroft- Gault calculation
    8. Are not breastfeeding, are not pregnant, and do not plan to become pregnant during the clinical trial
    9. Females with childbearing potential must provide a negative pregnancy test within the screening period and must be using adequate contraception (oral or injectable [depot] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method [e.g., condom and diaphragm or spermicidal gel]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before clinical trial start
    10. Males or females aged 18 years or older
    E.4Principal exclusion criteria
    1. Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor, or tumor invasion of a major blood vessels
    2. Metastatic disease (M1) Stage IV C
    3. Any prior history of head and neck cancer
    4. Prior radiation to the head and neck
    5. Plan to be treated with cetuximab (Erbitux®)
    6. Have undergone induction CT
    7. History of non-head and neck malignant tumors, excluding non-melanoma skin cancer or
    curatively excised in situ cervical carcinoma within the last 5 years
    8. Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the clinical trial
    9. Active infectious disease, excluding oral candidiasis
    10. Have a previous history, or exposure to active tuberculosis or histoplasmosis infection
    11. Have active tuberculosis or histoplasmosis infection
    12. Have OM at the screening visit
    13. Have a diagnosis of autoimmune disease requiring chronic immunosuppression, e.g. methotrexate
    14. Known seropositivity for HIV, HBV or HCV
    15. Prior use of ALD518 or other monoclonal antibody
    16. Have received any experimental, unregistered therapy (within or outside a clinical trial) within 30 days or five plasma half lives (whichever is longer) before dosing
    17. Unable to give informed consent or comply with clinical trial requirements, including completing the subject diary and PRO instruments
    18. Have any past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the clinical trial or unable to comply with follow-up visits
    19. Subjects who have a history of known symptomatic diverticulosis, diverticulitis, perforated diverticular diseases, or small bowel and/or upper GI perforation
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoint
    1. Safety and tolerability, including incidence of adverse events
    (AEs) and serious adverse events (SAEs), deaths, and clinically significant laboratory abnormalities
    Primary Efficacy Endpoint
    1. Clinically assessed ulcerative OM (WHO Grade ≥ 2) at a
    cumulative radiation dose of 55 Gy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Safety Endpoint
    1. Safety and tolerability will be assessd from randomization through the 12 month follow-up period.
    Primary Efficacy Endpoint
    1. Oral mucositis will be assessed from the screening visit through the 4 week post RT treatement period.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints
    1. Secondary efficacy endpoints will be evaluated through the Week
    4 Post-RT visit, as appropriate
    2. OM Assessments
    a. Ulcerative (WHO Grade ≥ 2) and severe (WHO Grade ≥ 3)
    OM at cumulative doses of 35 Gy, 45 Gy, 55 Gy and 65
    Gy
    b. Duration of ulcerative and severe OM
    c. Time of onset of ulcerative and severe OM
    3. Pain Assessments: Mouth and throat soreness associated with OM
    (as measured with OMDQ Question 2)
    4. Analgesic Consumption: Use of analgesics, expressed in morphine
    equivalents per 24 hours
    5. Patient Reported Outcomes (PRO): Patient-reported outcomes
    associated with HNC (as measured with the OMDQ and FACTHN)
    and FACIT-fatigue scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Endpoints
    1. N/A
    2. Oral mucositis will be assessed from the screening visit through the 4 week post RT treatment period.
    3. Pain assessments will be assessed utilizing the OMDQ subject diary from baseline through the 4 week post RT treatment period.
    4. Analgesic consumption will be assessed utilizing the OMDQ subject diary from baseline through the 4 week post RT treatment period.
    5. Patient Reported Outcomes will be assessed utilizing the OMDQ subject diary, FACT-HN and FACIT-F from baseline through the 4 week post RT treatment period.

    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 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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Canada
    Germany
    Italy
    United States
    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
    Patients will be followed for 1 year from randomization for survival data.
    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 months0
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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.1.1.1In 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 No
    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 31
    F.4.2.2In the whole clinical trial 96
    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 Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-02-08
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