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    Clinical Trial Results:
    An open-label, multicenter rollover study to provide continued treatment with anetumab ravtansine for participants with solid tumors who were enrolled in previous Bayer-sponsored studies

    Summary
    EudraCT number
    		 2019-000061-20
    Trial protocol
    		 FR   BE   PL   IT  
    Global end of trial date
    18 May 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jun 2023
    First version publication date
    14 May 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction for AE timeframe is needed.

    Trial information

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    Trial identification
    Sponsor protocol code
    20322
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03926143
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.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
    18 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study was a rollover study to permit subjects who received anetumab ravtansine in an applicable Bayer sponsored anetumab ravtansine parent study to continue treatment or follow-up at the time of parent study closure. Main objective is safety.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    10
    EEA total number of subjects
    4
    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)
    6
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 7 study centers in 4 countries worldwide between 03-Jun-2019 (first subject first visit) and 18-May-2022 (last subject last visit).

    Pre-assignment
    Screening details
    		 A total of 10 subjects were screened in this study; of whom 9 subjects started study treatment and 1 subject was a screening failure. Entering subjects had to have been treated with anetumab ravtansine in an applicable Bayer sponsored anetumab ravtansine parent study.

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

    Arms
    Arm title
    		 Anetumab ravtansine
    Arm description
    		 Adult subjects with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 subjects received anetumab ravtansine monotherapy and 1 subject received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine as per the dosing instructions from the parent study protocol.

    Investigational medicinal product name
    Anetumab ravtansine
    Investigational medicinal product code
    BAY94-9343
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Anetumab ravtansine as per the dosing instructions from the parent study protocol in an every 3 weeks (Q3W) schedule.

    Number of subjects in period 1 [1]
    		Anetumab ravtansine
    Started
    9
    Completed
    0
    Not completed
    9
         Physician decision
    3
         Adverse event, non-fatal
    2
         Subject decision: Covid-19 Pandemic related
    1
         Progressive disease
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 10 subjects were enrolled and 9 subjects started the treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anetumab ravtansine
    Reporting group description
    		 Adult subjects with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 subjects received anetumab ravtansine monotherapy and 1 subject received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

    Reporting group values
    		 Anetumab ravtansine Total
    Number of subjects
    		 9 9
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.7 ± 16.2 -
    Gender Categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 6 6
    Race
    Units: Subjects
        White
    		 6 6
        Asian
    		 2 2
        Not reported
    		 1 1
    Ethnicity
    Units: Subjects
        Unknown or Not Reported
    		 9 9

    End points

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    End points reporting groups
    Reporting group title
    Anetumab ravtansine
    Reporting group description
    		 Adult subjects with solid tumors who received anetumab-ravtansine treatment as monotherapy, or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 subjects received anetumab ravtansine monotherapy and 1 subject received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

    Primary: Number of subjects with TEAEs, TESAEs and Drug-related TEAEs and TESAEs

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    End point title
    		 Number of subjects with TEAEs, TESAEs and Drug-related TEAEs and TESAEs [1]
    End point description
    Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
    End point type
    Primary
    End point timeframe
    Approximately 3 years (from first study treatment until safety follow-up)
    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: As study was small and incoming population was heterogeneous and subject to selection bias, no inferential statistical analysis was performed.
    End point values
    		 Anetumab ravtansine
    Number of subjects analysed
    9
    Units: Subjects
        Any TEAE
    9
        Serious TEAE
    2
        Any study drug-related TEAE
    8
        Any study drug-related Serious TEAE
    0
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. 99999 indicates value cannot be estimated due to censored data.
    End point type
    Secondary
    End point timeframe
    Approximately 3 years (from first study treatment until safety follow-up)
    End point values
    		 Anetumab ravtansine
    Number of subjects analysed
    9 [2]
    Units: Months
    median (confidence interval 95%)
        25th percentile
    17.6 (6.9 to 34.1)
        Median
    34.1 (6.9 to 99999)
        75th percentile
    99999 (28.5 to 99999)
    Notes
    [2] - Number of subjects: with event (5) and censored (4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For TEAE: After the first study intervention up to 30 days after the end of study intervention, approximately 3 years. For the deaths (all causes) considers all deaths that occurred at any time during the study before the last contact.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Anetumab ravtansine
    Reporting group description
    		 Adult patients with solid tumors who received anetumab-ravtansine treatment as monotherapy,or in combination with gemcitabine in an applicable Bayer-sponsored anetumab ravtansine study. 8 subjects received anetumab ravtansine monotherapy and 1 subject received anetumab ravtansine in combination with gemcitabine. Pooled results were reported.

    Serious adverse events
    		 Anetumab ravtansine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Anetumab ravtansine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Pleural effusion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Investigations
    Schirmer's test abnormal
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    4
    Neutrophil count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Lipase increased
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Blood bilirubin increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Amylase increased
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    3
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    6
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Corneal abrasion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Sinus tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Lymphopenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    5 / 9 (55.56%)
         occurrences all number
    10
    Leukopenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Keratitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Corneal epithelial microcysts
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Corneal disorder
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Infections and infestations
    Skin infection
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Hypokalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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

    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.
    Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results.
    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.

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