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    Summary
    EudraCT Number:2012-000966-40
    Sponsor's Protocol Code Number:EC-FV-07
    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:2012-08-28
    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 number2012-000966-40
    A.3Full title of the trial
    A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive [FR(++)] Second Line NSCLC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Open-Label Phase 2 Study of EC145 Single-agent and the Combination of EC145 plus Docetaxel Versus Docetaxel Alone in Participants with Folate-Receptor Positive Second Line Non-small-cell lung carcinoma
    A.3.2Name or abbreviated title of the trial where available
    TARGET NSCLC:Trial to Assess benefit of folate-Receptor tarGEteted Treatment of second-line NSCLC
    A.4.1Sponsor's protocol code numberEC-FV-07
    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 SponsorEndocyte, 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 supportEndocyte, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEndocyte, Inc
    B.5.2Functional name of contact pointKen Carlson
    B.5.3 Address:
    B.5.3.1Street Address3000 Kent Avenue
    B.5.3.2Town/ cityWest Lafayette, Indiana
    B.5.3.3Post code47906
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17654637175
    B.5.5Fax number+17654639271
    B.5.6E-mailkcarlson@endocyte.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.3.2Product code EC20
    D.3.4Pharmaceutical form Powder for solution 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 INNetarfolatide
    D.3.9.1CAS number 479578-27-3
    D.3.9.2Current sponsor codeEC20
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeEC20 is to be labelled with 99mTc prior to administration; when an aqueous solution of freshly prepared metastable Tc is used to reconstitute EC20, the Tc is chelated and the imaging agent is formed
    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.3.2Product code EC145
    D.3.4Pharmaceutical form Powder for solution 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 INNvintafolide
    D.3.9.1CAS number 74209-03-1
    D.3.9.2Current sponsor codeEC145
    D.3.9.3Other descriptive namefolic acid desacetylvinblastine hydrazide conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.8
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Docetaxel
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDocetaxel
    D.3.4Pharmaceutical form Concentrate for solution for 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.4EV Substance CodeSUB12492MIG
    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 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
    Second line FR(++) non-small cell lung cancer (adenocarcinoma, squamous, adenosquamous, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study tests the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line NSCLC in participants with all target lesions expressing the folate receptor [FR(++)].
    Primary objective: progression free survival (PFS)
    E.2.2Secondary objectives of the trial
    Overall response rate (ORR=CR+PR), Duration of response (DOR), disease control rate (DCR=CR+PR+SD), duration of DCR, and overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must have the ability to sign an approved informed consent form (ICF).
    2. Participants must be ≥ 18 years of age.
    3. Participants must have histology confirmed diagnosis of NSCLC (adenocarcinoma, squamous, adenosquamous carcinoma, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).
    4. Participants must have all (RECIST v1.1-defined) target lesions positive for the folate receptor [FR(++)] by SPECT scan.
    5. Only one prior systemic therapy for advanced disease (e.g., a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor [EGFR] inhibitor).
    6. For the purpose of obtaining a RECIST v1.1 baseline scan, participants must have a radiological evaluation conducted no more than 28 days prior to beginning study therapy. Note: For participants with a history of CNS metastasis, or with current signs/symptoms of neurological compromise, baseline radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast).
    7. Participants must have radiologic evidence of disease progression following the most recent prior treatment.
    8. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1.
    9. Participants must have recovered (to baseline/stabilization) from prior cytotoxic therapy-associated acute toxicities.
    10. Participants with prior radiation therapy are eligible if they meet the following criteria:
    a. Previous radiation therapy is allowed to <25% of the bone marrow, but whole pelvis radiation is excluded.
    b. Prior radiotherapy must be completed at least 2 weeks before patient is randomized.
    c. Participants must have recovered from the acute toxic effects of the treatment before randomized.
    d. Prior thoracic radiation must be completed 30 days before study enrollment.
    e. Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions.
    f. Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions.
    11. Participants must have adequate organ function:
    a. Bone marrow reserve:i. Absolute neutrophil count (ANC) ≥ 1.5 x 10(9)/L. Platelets ≥ 100 x 10(9)/L. Hemoglobin ≥ 9 g/dL.
    ii. Use of supportive care measures (eg, use of white blood cell [WBC] growth factors, antiemetics, or epoetin) should follow ASCO guidelines. Participants should receive full supportive care, including transfusion of blood as mandated by clinical need; however, transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of EC145 and or docetaxel is administered are not allowed.
    b. Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase ≤ 2.5 x ULN.
    c. Renal: Serum creatinine ≤ 1.5 x ULN, or for participants with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min/1.73 m2 (50 mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).
    12. Participants of childbearing potential:
    a. Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to treatment with EC145 and/or docetaxel. If the pre-EC20 pregnancy test falls within 1 week prior to Cycle 1 Day 1, a repeat pregnancy test is not required.
    b. Women who are capable of becoming pregnant must practice an effective method of birth control (eg, oral, transdermal or injectable contraceptives, intrauterine device [IUD], double-barrier contraception, such as diaphragm and spermicidal jelly) or abstinence for the duration of their participation in the trial through 3 months following the last dose of EC145 and through 6 months following the last dose of docetaxel.
    c. Male participants who are sexually active must practice an effective method of birth control (eg, condom and spermicidal jelly or abstinence).Effective birth control methods must be used throughout study participation and for at least 3 months following the last dose of EC145 and at least 6 months following the last dose of docetaxel.
    E.4Principal exclusion criteria
    1. Prior therapy with docetaxel, vinorelbine, or vinca-containing compounds.
    2. Known hypersensitivity to docetaxel or polysorbate 80.
    3. Symptomatic central nervous system (CNS) metastases or metastases that result in midline shift, significant edema. Patients who received treatment for CNS metastases with steroids or anti-seizure medications should be off all medications for at least 7 days prior to randomization. At least 2 weeks should have elapsed from CNS radiotherapy (including WBRT, stereotactic radiotherapy, etc)
    4. Malignancies other than NSCLC that are expected to alter life expectancy or may interfere with disease assessment. For instance, patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer and patients with prior history of malignancy who have been disease-free for more than 3 years are eligible.
    5. Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
    6. Antifolate therapy such as methotrexate for rheumatoid arthritis).
    7. Baseline peripheral neuropathy CTCAE ≥ Grade 2.
    8. Pregnant or lactating women.
    9. Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
    10. Active infections (eg, hepatitis or HIV carriers)
    E.5 End points
    E.5.1Primary end point(s)
    Compare progression-free survival (PFS), based on investigator assessment using RECIST V1.1 in participants with 2nd line FR(++) NSCLC. Comparison of primary interest are: 1)EC145+docetaxel versus docetaxel and 2) EC145 single-agent versus docetaxel
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint for this study is PFS, defined as the duration from randomization to the first occurrence of either PD or death. A participant may be declared to have PD on the basis of RECIST v1.1-defined criteria. The date of disease progression is defined as the date of the radiologic assessment on which RECIST-defined progression is identified.
    E.5.2Secondary end point(s)
    Overall response rate (ORR=CR+PR), Duration of response (DOR), disease control rate (DCR=CR+PR+SD), duration of DCR, and overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR will be based on subjects achieving an OR. At each cycle of RECIST evaluation, actual measured tumor assessments will be used to determine whether subjects have an assessment of CR or PR, which will be considered as an OR. DCR will be based on participants achieving an overall best response of CR, PR, or stable disease.
    OS is defined as the duration from the date of randomization to the date of death from any cause. Subjects who are alive or lost to F-up at the time of the analysis will be censored at the last known date they were alive. If a subject has not died then OS will be censored at last study visit/last contact date/last date the subject was alive, whichever is more temporally distal.
    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 No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Poland
    Romania
    Russian Federation
    Spain
    United Kingdom
    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
    The last site will not be closed with their Ethics Committee until the last patient has completed Long Term Follow Up (LTFU)
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 135
    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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 180
    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)
    As per standard of care
    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 Decision2012-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-01
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