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    Clinical Trial Results:
    A single arm, open-label, Phase 2 study to assess the efficacy and safety of lucitanib given orally as a single agent to patients with advanced/metastatic lung cancer and FGF-, VEGF-, or PDGF-related genetic alterations

    Summary
    EudraCT number
    		 2013-003874-29
    Trial protocol
    		 IT   DE   ES  
    Global end of trial date
    26 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 May 2019
    First version publication date
    12 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    E-3810-II-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02109016
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clovis Oncology UK Ltd
    Sponsor organisation address
    Sheraton House, Castle Park, Cambridge, United Kingdom, CB3 0AX
    Public contact
    Dr Lindsey Rolfe, Clovis Oncology UK Ltd, +44 1223 370037, info@clovisoncology.com
    Scientific contact
    Dr Lindsey Rolfe, Clovis Oncology UK Ltd, +44 1223 370037, info@clovisoncology.com
    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
    26 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the objective response rate (ORR) of lucitanib in patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF)-, vascular endothelial growth factor (VEGF)-, or platelet-derived growth factor (PDGF)-related genetic alterations
    Protection of trial subjects
    A data monitoring committee (DMC) consisting of 2 of the clinical trial investigators and sponsor personnel met every 3-6 months during the study to review the efficacy and safety data, and provide recommendations regarding study continuation/discontinuation and protocol modifications.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Mar 2014
    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
    United States: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    18
    EEA total number of subjects
    14
    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)
    11
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 18 patients enrolled at 10 study centers from the US, Germany, Italy, Spain, and France; all 18 patients received at least one dose of lucitanib.

    Pre-assignment
    Screening details
    		 Eligible patients were ≥ 18 years of age with advanced/metastatic SCLC or NSCLC that had FGF, VEGF, or PDGF genetic alterations based on local or central testing, and had failed at least 1 prior treatment line.

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

    Arms
    Arm title
    		 Lucitanib 10mg or 15mg QD
    Arm description
    		 Starting dose of 10 or 15mg lucitanib depending on protocol version in force at the time of enrollment. Taken orally once daily (continuous 28 day treatment cycle). Patients were to continue treatment as long as, according to the investigator, continuation was in their best interest (ie, they appeared to be receiving clinical benefit), and unless there was occurrence of unacceptable toxicity, progressive disease (PD), or withdrawal of consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lucitanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose of 10mg or 15mg. Taken orally once daily (continuous 28 day treatment cycle). Patients were to take lucitanib at approximately the same time each day under fasting conditions (ie, at least 2 hours prior to and 2 hours after a meal), and to swallow lucitanib with a glass of water.

    Number of subjects in period 1
    		Lucitanib 10mg or 15mg QD
    Started
    18
    Completed
    0
    Not completed
    18
         Consent withdrawn by subject
    1
         Disease progression
    10
         Adverse event, non-fatal
    4
         Death
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 7 7
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 13 13
    Race
    Units: Subjects
        Black or African American
    		 3 3
        White
    		 4 4
        Missing
    		 11 11
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 8 8
        Unknown
    		 8 8
        Missing
    		 2 2
    Number of prior anticancer therapies
    Units: Number
        median (full range (min-max))
    		 3 (2 to 7) -

    End points

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    End points reporting groups
    Reporting group title
    Lucitanib 10mg or 15mg QD
    Reporting group description
    		 Starting dose of 10 or 15mg lucitanib depending on protocol version in force at the time of enrollment. Taken orally once daily (continuous 28 day treatment cycle). Patients were to continue treatment as long as, according to the investigator, continuation was in their best interest (ie, they appeared to be receiving clinical benefit), and unless there was occurrence of unacceptable toxicity, progressive disease (PD), or withdrawal of consent.

    Primary: Objective Response Rate (CR or PR) according to RECIST v 1.1 as determined by investigator

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    End point title
    		 Objective Response Rate (CR or PR) according to RECIST v 1.1 as determined by investigator [1]
    End point description
    Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 to End of Treatment
    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: Because of the early termination of the study, efficacy analyses were limited. Post-baseline tumor assessments were available for 13 of the 18 patients at the time of study discontinuation. Only one of 13 patients (7.7%) had a best response of confirmed PR. The duration of response for this patient was 113 days.
    End point values
    		 Lucitanib 10mg or 15mg QD
    Number of subjects analysed
    13
    Units: percentage of patients
    8
    No statistical analyses for this end point

    Secondary: Duration of Response according to RECIST v1.1

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    End point title
    		 Duration of Response according to RECIST v1.1
    End point description
    Duration of response in patients with confirmed response by investigator. Because of the early termination of the study, efficacy analyses were limited. Post-baseline tumor assessments were available for 13 of the 18 patients at the time of study discontinuation. Only one of 13 patients (7.7%) had a best response of confirmed PR. The duration of response for this patient was 113 days.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 to End of Treatment
    End point values
    		 Lucitanib 10mg or 15mg QD
    Number of subjects analysed
    1
    Units: Median number of days
    113
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug.
    Adverse event reporting additional description
    If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Lucitanib 10mg or 15mg QD
    Reporting group description
    		 Starting dose of 10 or 15mg depending on protocol version in force at the time of enrollment. Taken orally once daily (continuous 28 day treatment cycle). Patients were to continue treatment as long as, according to the investigator, continuation was in their best interest (ie, they appeared to be receiving clinical benefit), and unless there was occurrence of unacceptable toxicity, progressive disease (PD), or withdrawal of consent.

    Serious adverse events
    		 Lucitanib 10mg or 15mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 18 (66.67%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Pericardial effusion malignant
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Performance status decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Empyema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostate infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Tuberculosis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lucitanib 10mg or 15mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 18 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Metastases to central nervous system
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pericardial effusion malignant
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    14 / 18 (77.78%)
         occurrences all number
    79
    Hypotension
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    5
    Chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    13
    General physical health deterioration
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    4
    Oedema peripheral
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Performance status decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    4 / 18 (22.22%)
         occurrences all number
    5
    Dysphonia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    4
    Epistaxis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Haemoptysis
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Increased bronchial secretion
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pleuritic pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Pneumothorax
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Respiratory distress
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Respiratory failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Psychiatric disorders
    Distractibility
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Blood magnesium decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Ejection fraction decreased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Thyroxine free decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    5
    Weight decreased
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Hyperreflexia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Anal fistula
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Ascites
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Colitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    7
    Dysphagia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    3
    Rectal haemorrhage
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Stomatitis
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    3 / 18 (16.67%)
         occurrences all number
    4
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Nail toxicity
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    13
    Renal failure
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Renal failure acute
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Strangury
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Urinary retention
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Fistula
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infections and infestations
    Empyema
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Prostate infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2
    Septic shock
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Tuberculosis
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    7
    Dehydration
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences all number
    3
    Hypercalcaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 18 (5.56%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2015
    Expanded the patient population to include SCLC and NSCLC with adenomatous, squamous, and large cell histologies, as well as FGF, VEGF, or PDGF genetic alterations.
    23 Jul 2015
    Reduced the starting dose of lucitanib from 15 mg QD to 10 mg QD.
    27 Jan 2016
    Provided new guidance for the monitoring, lucitanib treatment interruption, and reporting of Posterior Reversible Encephalopathy Syndrome (PRES).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 Dec 2015
    Enrollment was closed early on 24 December 2015 because of poor accrual and changing development priorities. All patients currently in screening as of 24 December 2015 were permitted to complete screening activities and enroll on study (if eligible) to receive lucitanib treatment. The last patient was enrolled on 4 January 2016.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Analyses pertaining to secondary objectives (CBR, PFS, OS, kinetics of tumor size change, and PK) and the exploratory objectives were not performed because of early termination of the study.
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    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.

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