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    Summary
    EudraCT Number:2013-000548-25
    Sponsor's Protocol Code Number:PM1183-B-004-13
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-02
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-000548-25
    A.3Full title of the trial
    A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination with Gemcitabine and a control arm with Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients.
    Étude de phase II, randomisée, contrôlée, à trois bras, comparant la lurbinectedine (PM01183) seule ou en association avec la gemcitabine versus docétaxel comme traitement de deuxième intention chez des patients atteints de cancer bronchique non à petites cellules (CBNPC) non résécable 
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study in Three-arm of Lurbinectedin (PM01183) alone or in combination with Gemcitabine and a control arm with Docetaxel as second-line treatment in Small Cell Lung Cancer (NSCLC) patients.
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberPM1183-B-004-13
    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 SponsorPharma Mar S.A. Sociedad Unipersonal
    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 supportPharma Mar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A. Sociedad Unipersonal
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvda. De Los Reyes, no 1 Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo (Madrid)
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number3491846 60 00
    B.5.5Fax number3491846 60 03
    B.5.6E-mailclinicaltrials@pharmamar.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 namelurbinectedin
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for 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 INNlurbinectedin
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.4EV Substance CodeSUB31196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlurbinectedin
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.4EV Substance CodeSUB31196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 2
    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.2.5The 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 nameGemcitabine
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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 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.2.5The 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.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder 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.3.9.3Other descriptive nameANHYDROUS DOCETAXEL
    D.3.9.4EV Substance CodeSUB22289
    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
    Unresectable Non-Small Cell Lung Cancer (NSCLC).
    E.1.1.1Medical condition in easily understood language
    Unresectable Non-Small Cell Lung Cancer (NSCLC).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the antitumor activity as progression-freesurvival at four months (PFS4) of PM01183 alone or in combination with gemcitabine as second-line treatment in unresectable NSCLC patients, using single agent docetaxel as a reference in the control arm as current standard of care.
    E.2.2Secondary objectives of the trial
    *To analyze the following in each of the three treatment arms:
    - Time-to-event endpoints, such as: progression-free survival (PFS), overall survival (OS), overall survival rate at 1-year (OS12) and duration of response (DR).
    - Antitumor activity, as response rate (RR) evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    - Safety and efficacy profiles of PM01183 alone and in combination with gemcitabine, to be preliminary compared with docetaxel.
    - Patients’ quality of life (QoL) assessment.
    - To explore the feasibility and safety of a PM01183 maintenance dose in non-progressing NSCLC patients.
    - Pharmacokinetics (PK) of PM01183.
    - PK/PD (pharmacokinetic/pharmacodynamic)
    correlation in PM01183-based treated patients, whenever possible.
    *Pharmacogenomics (PGx): To explore potential correlations between molecular parameters found in previous available tumor samples and clinical outcomes
    achieved with PM01183-based treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic sub-study.
    E.3Principal inclusion criteria
    1) Voluntary written IC of the patient obtained before any study-specific procedure.
    2) Histologically or cytologically confirmed unresectable NSCLC.
    3) Patients must have failed one prior line of CT-based therapy for unresectable disease.
    4) Age between 18 and 75 years, both inclusive.
    5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
    6) Adequate hematological, renal, metabolic and hepatic function:
    a) Hemoglobin ≥ 9 g/dl (patients may have received prior red blood cell [RBC] transfusion up to 48 hours before
    treatment start, if clinically indicated), absolute neutrophil count (ANC) ≥ 2.0 x 109/l, and platelet count ≥ 100 x 109/l.
    b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
    c) Total bilirubin ≤ ULN.
    d) Albumin ≥ 3.0 g/dl.
    e) Calculated creatinine clearance (CrCl) ≥ 30 ml/minute (using Cockcroft and Gault’s formula).
    f) Creatine phosphokinase (CPK) ≤ 2.5 x ULN.
    7) At least four weeks (if the patient received a total dose ≥ 30 Gy)/two weeks (if the patient received a total dose < 30 Gy) since the last prior therapy, at least four weeks since completion of any prior radiotherapy and recovery to grade ≤ 1 from any adverse event (AE) derived from previous anticancer treatment, except alopecia, sensory neuropathy, anemia or asthenia (all of which must have recovered to grade ≤ 2) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v.4).
    8) Pre-menopausal women must have a negative pregnancy test before treatment start and not be breast feeding. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for at least six months after treatment discontinuation. Acceptable methods of contraception include intrauterine device (IUD), oral contraceptive,
    subdermal implant, double barrier and/or complete abstinence (non-periodic).

    1) Obtention du consentement éclairé écrit du patient avant le début de toute procédure spécifique de l'étude.
    2) CBNPC non résécable confirmé par histologie ou cytologie.
    3) Les patients doivent être en échec d’une première ligne de chimiothérapie.
    4) Âgé(e) de 18 à 75 ans.
    5) Indice de performance (PS; « performance status ») ECOG (« Eastern Cooperative Oncology Group ») ≤ 1.
    6) Fonctions hématologique, rénale, métabolique et hépatique adéquates.
    a) Hémoglobine ≥ 9 g/dL (les patients peuvent avoir reçu une transfusion de globules rouges [GR] jusqu'à 48 heures avant le début du traitement, si cliniquement indiqué), nombre absolu de polynucléaires neutrophiles (PNN) ≥ 2,0 x 109 /L, et nombre de plaquettes ≥ 100 x 109/L.
    b) Alanine aminotransférase (ALAT) et aspartate aminotransférase (ASAT) ≤ 3,0 x LSN (Limite Supérieure de la Normale).
    c) Bilirubine totale ≤ LSN.
    d) Albumine ≥ 3,0 g/dL.
    e) Clairance de la créatinine calculée (ClCr) ≥ 30 mL/minute (à l'aide de la formule de Cockcroft et Gault).
    f) Créatine phosphokinase (CPK) ≤ 2,5 × LSN.
    7) Délai d’au moins trois semaines après la dernière chimiothérapie, et d’au moins quatre semaines (si le patient a reçu une dose totale d’irradiation ≥ 30 Gy) / deux semaines (si le patient a reçu une dose totale d’irradiation < 30 Gy) après la fin de la dernière radiothérapie, et récupération jusqu’à un grade≤1 de tout évènement indésirable (EI) survenu lors du traitement anticancéreux précédent, à l'exception de l'alopécie, de la neuropathie sensorielle, de l'anémie ou de l'asthénie (desquels il faudra avoir récupéré jusqu’à un grade ≤ 2) selon le « National Cancer Institute Common Terminology Criteria for Adverse Events » (NCI-CTCAE, version 4).
    8) Les femmes en âge de procréer doivent avoir un test de grossesse négatif avant le début du traitement et ne pas allaiter. Les patients hommes et femmes doivent accepter d'utiliser une contraception appropriée pendant toute la durée de participation à l'étude et pendant au moins six semaines après la dernière dose de PM01183. Les méthodes de contraception appropriée comprennent l’utilisation de dispositif intra-utérin (DIU), la contraception orale, l’implant contraceptif sous-cutané, la double barrière et/ou l’abstinence totale (pas seulement périodique).
    E.4Principal exclusion criteria
    1) Concomitant diseases/conditions:
    a) History (within the last year) or presence of unstable angina, myocardial infarction, symptomatic congestive heart failure or asymptomatic with left ventricular ejection fraction (LVEF) ≤ 50% (assessed by multiple-gated acquisition scan [MUGA] or equivalent by ultrasound [US]) or clinically significant valvular heart disease.
    b) Patients with dyspnea at rest or requiring any oxygen support within the last four weeks.
    c) Known infection by human immunodeficiency virus (HIV), including seropositive patients without AIDs.
    d) Chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and Hepatitis B quantitative polymerase chain
    reaction (qPCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and Hepatitis C qPCR.
    e) Active uncontrolled infection; patients undergoing active antibiotherapy for an ongoing infection must have finished treatment at least one week before treatment start.
    f) Pleural or pericardial effusions requiring invasive management procedures.
    g) Known myopathy of any cause.
    h) Limitation of the patient’s ability to comply with the treatment or to follow-up the protocol.
    I) Any other major illness that, in the Investigator’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
    2) More than one prior line of CT for advanced or unresectable disease.
    3) Histological features of neuroendocrine or bronchioalveolar differentiation.
    4) Unknown epidermal growth factor receptor (EGFR) mutation status or previously known EGFR mutated status in patients with adenocarcinoma.
    5) Prior or concurrent invasive malignant disease, unless in complete remission for more than three years. Exceptions are completely resected or definitively treated squamous cell carcinoma of the cervix or head and neck without lymphatic spread, cutaneous basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
    6) Significant cancer-related weight loss (≥10%) within four weeks prior to treatment start.
    7) Prior treatment with gemcitabine or docetaxel-containing therapy (one full infusion at least completed).
    8) Symptomatic, steroid-requiring or progressive CNS involvement. If there is prior or current, known or suspected CNS involvement, clinical stability and lack of radiological progression of lesions should be demonstrated for at least the immediate six weeks before study entry.
    9) Ongoing symptomatic paraneoplastic syndromes.
    1) Maladies concomitantes :
    a) Antécédents (au cours de la dernière année) ou présence d’un angor instable, infarctus du myocarde, insuffisance cardiaque congestive symptomatique ou asymptomatique avec fraction d’éjection du ventricule gauche (FEVG) ≤ 50 % [évaluée par ventriculographie radio-isotopique « multiple-gated acquisition scan » (MUGA) ou équivalent par ultrasons (US)] ou maladie cardiaque valvulaire cliniquement significative.
    b) Les patients ayant souffert de dyspnée au repos ou nécessitant un apport d'oxygène au cours des quatre dernières semaines.
    c) Infection connue par le virus de l'immunodéficience humaine (VIH), y compris les patients séropositifs sans sida.
    d) Hépatite chronique active ou cirrhose. Pour l’hépatite B, cela comprend des tests positifs par détection de l’antigène de surface et par réaction en chaîne par polymérase quantitative (qPCR). Pour l’hépatite C, cela comprend des tests positifs par dosage des anticorps anti-hépatite C et par réaction en chaîne par polymérase quantitative (qPCR).
    e) Infection active non contrôlée ; les patients sous antibiothérapie active pour une infection en cours doivent avoir terminé le traitement au moins une semaine avant le début du traitement.
    f) Épanchements pleuraux ou péricardiques nécessitant des procédures de prise en charge invasives
    g) Myopathie connue, quelle qu’en soit la cause.
    h) Patient difficilement capable de se conformer au traitement et au suivi du protocole.
    i) Toute autre maladie importante qui, de l’avis de l’investigateur, augmentera de façon significative le risque associé à la participation du patient à l’étude.
    2) Plus d'une ligne antérieure de chimiothérapie pour un cancer avancé ou non résécable.
    3) Caractéristiques histologiques de différenciation neuro-endocrine ou broncho-alvéolaire.
    4) Statut de la mutation du récepteur du facteur de croissance épithélial (EGFR) inconnu ou mutation de l'EGFR précédemment établie chez les patients atteints d'un adénocarcinome.
    5) Affection maligne invasive antérieure ou simultanée, à moins qu'elle ne soit en rémission complète depuis plus de trois ans. Les exceptions incluent le carcinome épidermoïde du col de l'utérus, de la tête et du cou complètement réséqué ou traité de manière définitive et sans propagation lymphatique, un carcinome basocellulaire ou un carcinome cellulaire transitoire superficiel de la vessie.
    6) Perte de poids importante liée au cancer (≥10 %) au cours des quatre semaines avant le début du traitement.
    7) Un traitement préalable par thérapie incluant le docétaxel (au moins une perfusion complète réalisée).
    8) Implication progressive ou symptomatique du SNC, nécessitant des stéroïdes. En cas d'implication antérieure ou actuelle du SNC, connue ou suspectée, la stabilité clinique et l'absence de progression radiologique des lésions doivent être démontrées pendant au moins six semaines avant l'entrée dans l'étude.
    9) Syndromes paranéoplasiques symptomatiques en cours.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival rate at four months (PFS4), defined as the rate estimate of the percentage of patients
    who are alive and progression-free at 16 weeks (~4 months) after randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    December 2015.
    E.5.2Secondary end point(s)
    Overall response rate (ORR), Duration of response (DR), Progression-Free Survival (PFS), Overall Survival (OS), Overall Survival rate at 1 year (OS12), Treatment Safety, Quality of Life (QoL), Non-compartmental (NCA) PK parameters, Pharmacogenomics (PGx).
    E.5.2.1Timepoint(s) of evaluation of this end point
    December 2015.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Gemcitabine / Docetaxel
    E.8.2.4Number of treatment arms in the trial3
    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 EEA15
    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
    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
    Nine months after the last treatment discontinuation of the last patient, or twelve months after accrual of the last evaluable patient (whichever occurs first), provided all patients who are still alive have had at least 12 months survival follow-up.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    The expected normal treatment of that condition.
    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 Decision2013-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-24
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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