Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2009-018148-45
    Trial protocol
    		 IT  
    Global end of trial date
    05 Apr 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    13621
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01165021
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: H3E-EW-JMIP
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Apr 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Nov 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participant Flow reports participants who discontinued from study treatment. Completed participants were those who had a baseline tumor assessment, finished 3 cycles (Cy) of pre-operative chemotherapy (chemo), and had a second tumor assessment following chemo.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pemetrexed + Cisplatin
    Arm description
    		 Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles. All participants that entered into the study were also administered folic acid, vitamin B12 supplementation and dexamethasone prophylaxis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles

    Investigational medicinal product name
    Folic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally.

    Investigational medicinal product name
    Vitamin B12
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Administered Intramuscular injection.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally.

    Number of subjects in period 1
    		Pemetrexed + Cisplatin
    Started
    19
    ≥1 Dose Chemo
    19
    ≥1 dose chemo, baseline, Cy 3 assessment
    17 [1]
    3 cycles of Chemo, then Surgery
    15 [2]
    Completed
    18
    Not completed
    1
         Adverse event, serious fatal
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 17 participants had >=1 dose of chemotherapy, baseline and cycle 3 assessment.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 15 participants had 3 cycles of chemotherapy and then surgery.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Pemetrexed + Cisplatin
    Reporting group description
    		 Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles. All participants that entered into the study were also administered folic acid, vitamin B12 supplementation and dexamethasone prophylaxis.

    Reporting group values
    		 Pemetrexed + Cisplatin Total
    Number of subjects
    		 19 19
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ( 9.32 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 6 6
        Male
    		 13 13
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 19 19
    Region of Enrollment
    Units: Subjects
        Italy
    		 19 19
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    ECOG classifies participants according to their functional impairment. Scores range from 0 (fully active) to 5 (death). 0 (fully active, able to carry on all pre-disease performance without restriction) and 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
    Units: Subjects
        ECOG 0
    		 15 15
        ECOG 1
    		 4 4
    Initial Pathological Diagnosis
    Initial cancer diagnosis confirmed by tissue biopsy.
    Units: Subjects
        Adenocarcinoma, Lung
    		 17 17
        Carcinoma, Large Cell, Lung
    		 1 1
        Carcinoma, Non-Small Cell, Lung
    		 1 1
    Tumor-Node-Metastasis (TNM) Stage of Disease
    Tumor size: T1=surrounded by lung or visceral pleura with no evidence of invasion more proximal than lobar bronchus; T1a ≤2 centimeters (cm) at greatest dimension (GD); T1b >2 cm, ≤3 cm at GD; T2=involves main bronchus, ≥2 cm distal to carina; invades visceral pleura, associated with atelectasis or obstructive pneumonitis extends to hilar but not entire lung; T2a >3 cm, ≤5 cm at GD; T2b >5 cm, ≤7 cm at GD; T3= >7 cm or 1 that invades the thoracic cavity. Nodal status (N): N2 =Metastasis in ipsilateral mediastinal and/or subcarinal lymph nodes. Distant metastasis (M): M0 =No distant metastasis.
    Units: Subjects
        T1aN2M0
    		 3 3
        T1bN2M0
    		 2 2
        T2aN2M0
    		 3 3
        T2bN2M0
    		 3 3
        T3N2M0
    		 8 8
    Tobacco Consumption Status
    Units: Subjects
        Current Tobacco User
    		 4 4
        Former Tobacco User
    		 12 12
        Never Used Tobacco
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pemetrexed + Cisplatin
    Reporting group description
    		 Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles. All participants that entered into the study were also administered folic acid, vitamin B12 supplementation and dexamethasone prophylaxis.

    Primary: Percentage of participants with complete response (CR) or partial response (PR) [Overall Response Rate (ORR)]

    		 Close Top of page
    End point title
    		 Percentage of participants with complete response (CR) or partial response (PR) [Overall Response Rate (ORR)] [1]
    End point description
    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. Analysis Population Description: Participants who received at least 1 dose of preoperative chemotherapy and had baseline and Cycle 3 scans for tumor assessment.
    End point type
    Primary
    End point timeframe
    From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Unable to provide statistical analysis for single-arm study with no comparison group due to system limitations.
    End point values
    		 Pemetrexed + Cisplatin
    Number of subjects analysed
    17
    Units: percentage of participants
        number (confidence interval 95%)
    41.2 (18.4 to 67.1)
    No statistical analyses for this end point

    Secondary: Percentage of participants with No viable tumor cells in resected lung tissue [Pathological Complete Remission (pCR)]

    		 Close Top of page
    End point title
    		 Percentage of participants with No viable tumor cells in resected lung tissue [Pathological Complete Remission (pCR)]
    End point description
    pCR after the participant has undergone surgery was calculated as: (total number of participants with pCR) divided by (the total number of participants in pathological response population) multiplied by 100. Analysis Population Description: Participants who received at least 1 dose of preoperative chemotherapy and had surgical tumor tissue samples available.
    End point type
    Secondary
    End point timeframe
    At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy)
    End point values
    		 Pemetrexed + Cisplatin
    Number of subjects analysed
    15
    Units: percentage of participants
        number (confidence interval 95%)
    93.3 (68.1 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants who exhibit a downward shift in tumor extent from stage IIIAN2 to stages IIIA, II, I, or Stage 0

    		 Close Top of page
    End point title
    		 Percentage of participants who exhibit a downward shift in tumor extent from stage IIIAN2 to stages IIIA, II, I, or Stage 0
    End point description
    Tumor downstaging compared to baseline (Stage IIIAN2) were those participants who exhibited a downward shift in tumor extent from Stage IIIAN2 to Stages IIIA, II, I, or 0 were reported. Downstaging was based on radiological examination. Stage IIIAN2 was locally advanced and/or involved lymph nodes, metastasis in ipsilateral mediastinal and or subcarinal lymph nodes, tumors were ≤2 centimeters (cm) up to 5 cm in greatest dimension; Stage IIIA was locally advanced and/or involved lymph nodes, tumor extension was restricted to the affected lung; Stage II was locally advanced and/or involved lymph nodes; Stage I was small localized cancers, usually curable; Stage 0 the cancer did not spread beyond the inner lining of the lung. Missing responses were also reported. Percentage of participants calculated as: (number of participants with a downward shift in extent of their tumor) divided by (total number of evaluable participants) multiplied by 100.
    End point type
    Secondary
    End point timeframe
    From study enrollment until disease progression or recurrence up to completion of 3 cycles(cy)(21-day cy) of chemotherapy(CTH) Population:Participants who received at least 1 dose of preoperative CTH and had baseline and Cy 3 scans for tumor assessment
    End point values
    		 Pemetrexed + Cisplatin
    Number of subjects analysed
    17
    Units: percentage of participants
    number (confidence interval 95%)
        No Change or Worsening of Tumor Stage
    29.4 (10.3 to 56)
        Change to Stage IIIA
    29.4 (10.3 to 56)
        Change to Stage II
    11.8 (1.5 to 36.4)
        Change to Stage I
    17.6 (3.8 to 43.4)
        Missing
    11.8 (1.5 to 36.4)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive. Analysis Population Description : All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=8.
    End point type
    Secondary
    End point timeframe
    Enrollment until the date of death from any cause up to 64 months
    End point values
    		 Pemetrexed + Cisplatin
    Number of subjects analysed
    19 [2]
    Units: months
        median (confidence interval 95%)
    34.6 (10.8 to 9999)
    Notes
    [2] - 9999 = NA. Upper range of 95% confidence interval were not calculated due to high censoring rate.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause. For participants not known to have died or did not have objective progressive disease (PD) as of the data inclusion cut-off date, PFS was censored at the date of the last objective progression-free disease assessment. PD was defined using RECIST v1.1 criteria as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Analysis Population Description: All participants who received 1 or more doses of preoperative chemotherapy. Participants censored=3.
    End point type
    Secondary
    End point timeframe
    Enrollment until the first date of objectively determined PD or death up to 64 months
    End point values
    		 Pemetrexed + Cisplatin
    Number of subjects analysed
    19
    Units: months
        median (confidence interval 95%)
    12.4 (7 to 21.7)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment
    Adverse event reporting additional description
    H3E-EW-JMIP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Pemetrexed+Cisplatin
    Reporting group description
    		 -

    Serious adverse events
    		 Pemetrexed+Cisplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 19 (10.53%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    paraneoplastic syndrome
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    acute abdomen
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pemetrexed+Cisplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 19 (78.95%)
    Vascular disorders
    hypotension
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    fatigue
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    7
    oedema peripheral
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    pyrexia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    depressive symptom
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    irritability
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Investigations
    neutrophil count decreased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    6
    platelet count decreased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    anaemia postoperative
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    dysgeusia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    headache
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    syncope
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    neutropenia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Eye disorders
    lacrimation increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    apical granuloma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    constipation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    diarrhoea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    dysphagia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    haemorrhoids
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    nausea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 19 (21.05%)
         occurrences all number
    5
    oral dysaesthesia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    stomatitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 19 (15.79%)
         occurrences all number
    3
    vomiting
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    cafe au lait spots
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Renal and urinary disorders
    cystitis noninfective
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    myalgia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    pain in extremity
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    herpes zoster
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    tooth abscess
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Mar 2013
    Enrollment was stopped due to difficulties identifying suitable participants and enrollment delays.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to difficulties identifying suitable participants and enrollment delays, entries were closed after 26 of planned 33 participants signed consent. Results based on 19 participants who received ≥1 dose of chemotherapy. View results with caution.
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 04:23:04 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA