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    Clinical Trial Results:
    A randomized, multicenter open label phase II trial of Paclitaxel + Ramucirumab versus Paclitaxel alone in patients with squamous-cell carcinoma of the esophagus, refractory or intolerant to combination therapy with Fluoropyrimidine or Platinum-based drugs

    Summary
    EudraCT number
    2016-003850-33
    Trial protocol
    DE  
    Global end of trial date
    25 Nov 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Oct 2023
    First version publication date
    28 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RAMOS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03762564
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    AIO-STO-0216/ass: AIO
    Sponsors
    Sponsor organisation name
    Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    Sponsor organisation address
    Steinbacher Hohl 2-26, Frankfurt am Main, Germany, 60488
    Public contact
    Dr. Claudia Pauligk, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, ramos@ikf-khnw.de
    Scientific contact
    Dr. Claudia Pauligk, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, ramos@ikf-khnw.de
    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 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the efficacy of ramucirumab plus paclitaxel versus paclitaxel alone measured by overall survival rate at 6 months in patients with squamous cell carcinoma of the esophagus refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.
    Protection of trial subjects
    This clinical study was designed and shall be implemented and reported in accordance with the protocol, the AMG (Arzneimittelgesetz), the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki. The trial was authorized/approved by the competent authority (Paul-Ehrlich-Institut, PEI) and the competent ethics committee responsible for the trial (“federführende Ethikkommission”). Before recruitment into the clinical trial, each patient was informed that participation in the study is completely voluntary, and that he or she may withdraw his or her participation in the trial at any time without any declaration of reasons, which will not lead to any disadvantage for the respective patient. The eligibility of a new patient was determined by the local investigator during regular clinical visits. The examinations for the study and the inclusion of the patient were done after detailed written and oral education about aims, methods, anticipated benefits and potential hazards of the study by use of the informed consent forms and after given written consent of the patient. Safety of paclitaxel alone or in combination with ramucirumab was monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. An independent data safety monitoring board (DSMB) was responsible for assessment of reports summarizing safety data or study results and gave recommendations for planned protocol.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    186 patients for were planned. Due to slow recruitment and changes in the therapy landscape the trial was prematurely terminated. The recruitment period was 28 months, March 2019 - June 2021 and took place in 26 centers in Germany.

    Pre-assignment
    Screening details
    patients with metastatic or locally advanced squamous-cell carcinoma of the esophagus, refractory to or intolerant of prior platinum and fluoropyrimidine combination therapy were enrolled 27 patients were screened, 6 were refused participation due to ineligibility of inclusion/exclusion criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Investigational arm
    Arm description
    Patients received paclitaxel in combination with ramucirumab
    Arm type
    Experimental

    Investigational medicinal product name
    Ramucirumab
    Investigational medicinal product code
    Other name
    CYRAMZA
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use, Infusion
    Dosage and administration details
    8 mg/kg as 1 hour intravenous infusion on day 1 and 15 of each 28-day cylce; for up to one year

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 of each 28-day cycle, for up to one year

    Arm title
    Control arm
    Arm description
    Patients received paclitaxel monotherapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion , Intravenous use
    Dosage and administration details
    80 mg/m2 as 1 hour intravenous infusion on day 1, 8, 15 of each 28-day cycle, for up to one year

    Number of subjects in period 1
    Investigational arm Control arm
    Started
    11
    10
    Completed
    1
    0
    Not completed
    10
    10
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    -
         Death
    1
    -
         Lack of efficacy
    6
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    Patients received paclitaxel in combination with ramucirumab

    Reporting group title
    Control arm
    Reporting group description
    Patients received paclitaxel monotherapy

    Reporting group values
    Investigational arm Control arm Total
    Number of subjects
    11 10 21
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    66 (43 to 76) 62 (56 to 68) -
    Gender categorical
    Units: Subjects
        Female
    4 2 6
        Male
    7 8 15
    ECOG Performance
    Units: Subjects
        Status 0
    4 6 10
        Status 1
    7 4 11
    Tumor localization
    Units: Subjects
        Upper esophagus
    5 4 9
        Middle esophagus
    5 3 8
        Lower esophagus
    1 3 4
    Presence of metastases (at study entry)
    Units: Subjects
        NO
    1 2 3
        YES
    10 8 18
    Status of prior platinum/fluoropyrimidine combination therapy
    Units: Subjects
        Refractory
    9 7 16
        Intolerant
    2 3 5
    Prior resection
    Units: Subjects
        Of primary tumor
    2 5 7
        Of metastases
    0 1 1
        NO
    9 4 13

    End points

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    End points reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    Patients received paclitaxel in combination with ramucirumab

    Reporting group title
    Control arm
    Reporting group description
    Patients received paclitaxel monotherapy

    Primary: Overall survival rate at 6 months

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    End point title
    Overall survival rate at 6 months
    End point description
    defined at the proportion of all intention-to-treat patients being known to be alive at 6 months after randomisation
    End point type
    Primary
    End point timeframe
    from randomisation to 6 months after randomisation
    End point values
    Investigational arm Control arm
    Number of subjects analysed
    11
    10
    Units: percent
    number (confidence interval 95%)
        Alive
    72.7 (39 to 94)
    50 (19 to 81)
    Statistical analysis title
    Fisher exact test
    Comparison groups
    Investigational arm v Control arm
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.387
    Method
    Fisher exact
    Confidence interval

    Secondary: Progression-free survival

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    End point title
    Progression-free survival
    End point description
    Patients without any documentation of events are censored at their date of end of study respectively at the last date known to be progression-free
    End point type
    Secondary
    End point timeframe
    from randomization to the first documented evidence of disease progression or death
    End point values
    Investigational arm Control arm
    Number of subjects analysed
    11
    10
    Units: month
    median (confidence interval 95%)
        median PFS
    3.79 (0.69 to 7.56)
    3.53 (1.51 to 5.59)
    Attachments
    Untitled (Filename: RAMOS PFS.png)
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    Overall survival
    End point description
    Patients without any documentation of events are censored at their date of end of study respectively at the last date known to be alive.
    End point type
    Secondary
    End point timeframe
    from randomization to death from any cause
    End point values
    Investigational arm Control arm
    Number of subjects analysed
    11
    10
    Units: month
    median (confidence interval 95%)
        median OS
    12.09 (3.29 to 9999999)
    9.22 (2.00 to 99999999)
    Attachments
    Untitled (Filename: RAMOS OS.png)
    No statistical analyses for this end point

    Secondary: Tumor response acc. to RECIST 1.1

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    End point title
    Tumor response acc. to RECIST 1.1
    End point description
    End point type
    Secondary
    End point timeframe
    from randomization to end of study
    End point values
    Investigational arm Control arm
    Number of subjects analysed
    11
    10
    Units: Subjects
        Complete response (CR)
    0
    0
        Partial response (PR)
    2
    2
        Stable disease (SD)
    4
    4
        Progressive diesase (PD)
    3
    4
        Objective response rate (CR+PR)
    2
    2
        Tumor control rate (CR + PR + SD)
    6
    6
        Missing
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from signing of informed consent up to 30 days after last dose of study treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Investigational arm
    Reporting group description
    Patients received paclitaxel in combination with ramucirumab

    Reporting group title
    Control arm
    Reporting group description
    Patients received paclitaxel monotherapy

    Serious adverse events
    Investigational arm Control arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    5 / 10 (50.00%)
         number of deaths (all causes)
    6
    6
         number of deaths resulting from adverse events
    0
    1
    Investigations
    Hospitalization due to vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Progressive disease
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Stenosis
    Additional description: Left leg
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophageal fistula
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Other
    Additional description: Recurrence of purulent respiratory tract infection under oncological systemic therapy
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain lumbar vertebra
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchial infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Origin unknown infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Investigational arm Control arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    10 / 10 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Edema limbs
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 11 (18.18%)
    4 / 10 (40.00%)
         occurrences all number
    2
    7
    Fever
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Other
    Additional description: toxicity, Hematoxic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    ankle edema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Other
    Additional description: pressure on the upper abdomen
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 10 (40.00%)
         occurrences all number
    1
    8
    Thrombocytopenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Weight increased
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Weight decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    6 / 11 (54.55%)
    4 / 10 (40.00%)
         occurrences all number
    10
    17
    Injury, poisoning and procedural complications
    Cat Bite
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 10 (20.00%)
         occurrences all number
    4
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 10 (40.00%)
         occurrences all number
    3
    9
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Dysphagia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Other
    Additional description: occasional running bowel movement
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mucositis oral
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Rash acneiform
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Exanthem nose
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Joint pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    lumbar vertebra pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchial infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Port infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Lung infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2020
    - Opening of the study (inclusion criterion 3) to patients who are refractory or intolerant to fluoropyrimidine OR platinum-based prior therapy - Exclusion criterion 2: no exclusion of patient who receives additive parenteral nutrition - Deletion of exclusion criterion 3 - Exclusion criterion 4: limitation to Paclitaxel prior therapies in metastatic setting
    04 Jun 2020
    Reformulation Inclusion criterion 2: "Adult patients with metastatic or locally advanced squamous-cell carcinoma of the esophagus, not amenable to potentially curative resection, who are refractory to or intolerant of prior platinum and fluoropyrimidine combination therapy. An exception are patients with a contraindication for platinum or fluoropyrimidine or who refused therapy with one of the substances. Those patients are eligible after previous therapy with one of the substances."

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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