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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2015-000547-17
    Sponsor's Protocol Code Number:FPA008-002
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000547-17
    A.3Full title of the trial
    A Phase 1/2 Study of FPA008, an anti-CSF1 Receptor Antibody, in Patients with Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the safety and tolerability of FPA008
    A.3.2Name or abbreviated title of the trial where available
    Phase 1/2 of FPA008 in PVNS/dt-TGCT
    A.4.1Sponsor's protocol code numberFPA008-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02471716
    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 SponsorFive Prime Therapeutics, 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 supportFive Prime Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFive Prime Therapeutics, Inc.
    B.5.2Functional name of contact pointHelen Collins, MD
    B.5.3 Address:
    B.5.3.1Street AddressTwo Corporate Drive
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080-7047
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650 7459633
    B.5.5Fax number+14153655601
    B.5.6E-mailhelen.collins@fiveprime.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1799
    D.3 Description of the IMP
    D.3.2Product code FPA008
    D.3.4Pharmaceutical form 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 INNcabiralizumab
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeFPA008
    D.3.9.3Other descriptive nameHumanised IgG4 monoclonal antibody with high affinity binding to human colony stimulating factor 1 receptor
    D.3.9.4EV Substance CodeSUB33114
    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 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
    Pigmented villonodular synovitis (PVNS)/Diffuse Type Tenosynovial Giant Cell Tumor (dt-TGCT)
    E.1.1.1Medical condition in easily understood language
    Joint disease involving inflammation and overgrowth of the joint lining
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047413
    E.1.2Term Villonodular synovitis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: to determine the recommended dose (RD) of cabiralizumab in patients with PVNS/dt-TGCT
    Phase 2: to estimate the objective response rate (ORR = CR+PR) of cabiralizumab in patients with PVNS/dt-TGCT
    E.2.2Secondary objectives of the trial
    to characterize the safety and tolerability of cabiralizumabin patients with PVNS/dt-TGCT
    to determine the duration of response in responding patients
    to assess the pharmacokinetics of cabiralizumab in patients with PVNS/dt-TGCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients enrolling into Phase 1 or Phase 2 must meet all of the following
    inclusion criteria:
    1. Understand and sign an Institutional Review Board/Independent Ethics Commitee-approved informed consent form prior to any study specific evaluation
    2. Age ≥18 years
    3. Histologically confirmed diagnosis of inoperable PVNS/dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multidisciplinary tumor board (must be documented in the CRF during
    screening)
    4. Measurable PVNS/dt-TGCT by RECIST v1.1 on MRI
    5. ECOG performance status ≤1
    6. Willing and able to comply with all study procedures
    7. In sexually-active patients (i.e., females of childbearing potential, who have not undergone menopause as defined by 12 consecutive months of amenorrhea or had a permanent sterilization procedure and males, who have not had a permanent sterilization procedure), willingness to use 2 effective methods of contraception, of which one must be a physical barrier method (condom, diaphragm, or cervical/vault cap) during the study and until 6 months after the last dose of cabiralizumab. Other effective forms of contraception are permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to Screening. Females <55 years of age should have FSH >40. Female patients of childbearing potential must be on stable oral contraceptive therapy or intrauterine or implant device for at least 90 days prior to the study, or abstain from sexual intercourse as a way of living.
    8. Patients being retreated with cabiralizumab must have completed 6
    Cycles of initial treatment at the 1 mg/kg or 2 mg/kg dose levels and the End-of- Treatment Follow-Up Period.
    Note: Prior to re-treatment, patients will be re-assessed to ensure they meet the same eligibility requirements as untreated patients.
    9. Patients must have a minimum average Brief Pain Inventory (BPI)
    score of two points during screening (based on the average of questions 3-6 of the BPI, assessed for at least 5 of 14 days prior to C1D1; see Appendix 7).
    10. Patients must be on a stable analgesic regimen for two weeks prior to first dose.

    No waivers of these inclusion criteria will be granted.
    E.4Principal exclusion criteria
    Patients enrolling into Phase 1 or Phase 2 will be excluded if any of the following criteria apply:
    1. Prior therapy with another anti-CSF1R antibody within three months
    of first study dose administration (Note: Patients that discontinued prior anti-CSF1R antibody due to a drug-related serious adverse events will not be permitted to enroll)
    2. Prior therapy with pexidartinib (PLX3397), imatinib, or nilotinib within four weeks of first study dose administration
    3. Liver function tests (including AST, ALT, and total bilirubin), outside of the range of local laboratory normal at Screening
    4. Inadequate organ or bone marrow function defined as: hemoglobin <10 g/dL, absolute neutrophil count <1.5x 109/L, platelet count <100x
    109/L, serum creatinine >1.5x ULN or calculated creatinine clearance <30 mL/min
    5. Any surgical procedure of the involved joint within 12 weeks prior to first study dose administration (except baseline synovium biopsy, if performed)
    6. Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels
    7. History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration
    8. Decreased cardiac function with NYHA > Class 2
    9. Uncontrolled or significant heart disorder such as unstable angina
    10. Significant abnormalities on ECG at Screening. QTcF >450 msec for males or >470 msec for females at Screening
    11. Contraindications to MRI and use of intravenous gadolinium-based contrast agents
    12. History of severe allergic, anaphylactic, or other infusion related reaction to a previous biologic agent
    13. Treatment with any anticancer therapy or participation in another therapeutic clinical study with investigational drugs ≤ 28 days prior to first dose of cabiralizumab
    14. Known history of ADAs to previous biologic agents
    15. Known history of sensitivity to any component of the study drug formulation
    16. Consumption of non-pasteurized milk on a regular basis, or known significant risk of exposure to opportunistic intracellular infections such as listeria, or other such pathogens.
    17. Receipt of any vaccine within 28 days prior to first day of treatment. The effect of cabiralizumab on mounting an immunologic vaccine response is not known. Flu or other vaccinations may be administered while on study but the impact of cabiralizumab on the safety and efficacy of the vaccination is unknown.
    18. Current unresolved infection or chronic active clinically significant infection (viral [e.g., HBV, HCV], bacterial, fungal, or other) which in the opinion of the Investigator would place the patient at risk from exposure to a CSF1R inhibitor
    19. Known positive test for human immunodeficiency virus (HIV)
    20. Active TB
    21. Positive test for latent TB at Screening (T-spot or Quantiferon test)
    22. History of prior malignancy, except:
    –Curatively treated non-melanoma skin malignancy
    –Cervical cancer in situ
    –Solid tumor treated curatively more than 2 years previously without evidence of recurrence
    23. Lack of peripheral venous access or any condition that would interfere with drug administration or collection of study samples
    24. Any uncontrolled medical condition or psychiatric disorder which in the opinion of the Investigator would pose a risk to patient safety or interfere with study participation or interpretation of individual patient results
    25. Inability to perform and/or comply with study and follow-up procedures
    26. Known history of metastatic PVNS/dt-TGCT
    27. Creatine kinase (CK) ≥ 1.5x ULN
    28. Patients with a Screening anti-nuclear antibody (ANA) titer of 1:160
    or higher
    29. Active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

    No waivers of these exclusion criteria will be granted.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: The incidence of Grade 3 and Grade 4 adverse events (AEs) and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs)
    Phase 2: The incidence of confirmed objective responses per RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    See protocol
    E.5.2Secondary end point(s)
    PK parameters
    - the incidence of AEs, clinical laboratory abnormalities, and ECG abnormalities
    - duration of response per RECIST v1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/2 study
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    France
    Korea, Republic of
    Netherlands
    Poland
    United Kingdom
    United States
    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 Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 75
    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 Decision2015-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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