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    Clinical Trial Results:
    Perioperative chemotherapy with FOLFOX plus Cetuximab versus adjuvant FOLFOX plus Cetuximab for patients with resectable liver metastases of colorectal carcinoma

    Summary
    EudraCT number
    2008-005312-41
    Trial protocol
    DE   AT  
    Global end of trial date
    31 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    26 May 2016
    First version publication date
    26 May 2016
    Other versions
    Summary report(s)
    ClinicalTrialReport2008-005312-41

    Trial information

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    Trial identification
    Sponsor protocol code
    Panter_2008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01266187
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    RWTH Aachen University, Mrs Dipl. Biol. Verena Deserno
    Sponsor organisation address
    Pauwelsstraße 30, Aachen, Germany, 52074
    Public contact
    Verena Deserno, RWTH Aachen University, Clinical Trials Center Aachen (CTC-A),, 49 2418035849, vdeserno@ukaachen.de
    Scientific contact
    Verena Deserno, RWTH Aachen University, Clinical Trials Center Aachen (CTC-A),, 49 2418035849, vdeserno@ukaachen.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
    22 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The first primary objective of the study is to compare the postoperative complication rate according to Clavien score (> grade 1) of a perioperative chemotherapy with a postoperative regimen. A second primary objective of the study is to compare for the patient subgroup with >3 liver metastases or at least one metastasis ≥ 5 cm in diameter the median disease free survival.
    Protection of trial subjects
    The included cancer patients were treated with morphine derivatives as pain relievers if necessary.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2011
    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
    Germany: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    10
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients will be recruited in large centres. Patients with resectable colorectal liver metastases who are willing to participate will enter the screening phase. Prior to the start, subjects will perform the screening period in order to check if all eligibility criteria are fulfilled. Eligible patients will be randomized wihtin 3 weeks.

    Pre-assignment
    Screening details
    Inclusion criteria: signed written informed consent; ≥ 18 years; Proven K-RAS wildtype in primary tumour or metastasis tissue; Diagnosis of resectable metachronous liver-metastases after complete resection (R0) of primary tumour without gross or microscopic evidence of residual disease

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A
    Arm description
    12 postoperative cycles of Cetuximab and FOLFOX
    Arm type
    Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    ERBITUX
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    initial dose 400 mg/m2 and subsequent weekly doses of 250 mg/m2

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m²

    Investigational medicinal product name
    5-Fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use, Intravenous bolus use
    Dosage and administration details
    400 mg/m² i.v. bolus followed by 2400 - 3000 mg/m² continuous infusion

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² infusion (2 h)

    Arm title
    Arm B
    Arm description
    6 cycles before sugery and 6 cycles after the surgery
    Arm type
    Experimental

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    ERBITUX
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    initial dose 400 mg/m2 and subsequent weekly doses of 250 mg/m2

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m²

    Investigational medicinal product name
    5-Fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    400 mg/m² i.v. bolus followed by 2400 - 3000 mg/m² continuous infusion

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    85 mg/m² infusion (2 h)

    Number of subjects in period 1
    Arm A Arm B
    Started
    11
    13
    Completed
    11
    13

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    12 postoperative cycles of Cetuximab and FOLFOX

    Reporting group title
    Arm B
    Reporting group description
    6 cycles before sugery and 6 cycles after the surgery

    Subject analysis set title
    ITT Analysis
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Since the study was stopped prematurely, all analyses were done for the ITT-set, except the safety analyses, which were done for the safety population and the primary endpoint analysis, which was done for the surgery population. Results will be presented overall and according to the following treatment arms Arm A: Surgery → 4-8 weeks rest → 24 weeks FOLFOX + Cetuximab Arm B: 12 weeks FOLFOX + Cetuximab → 4 weeks rest → surgery → 4-8 weeks rest → 12 weeks FOLFOX + Cetuximab

    Primary: The primary endpoint is the post-operative complication rate (Clavien score > grade 1) up to the 30th postoperative day or the day of discharge from hospital

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    End point title
    The primary endpoint is the post-operative complication rate (Clavien score > grade 1) up to the 30th postoperative day or the day of discharge from hospital
    End point description
    12.3.1 Hypotheses for the First Primary Endpoint The null hypothesis is that the postoperative complication rate (≥ grade I according Dindo et.al.) is equal between the arm treated with perioperative therapy and the arm treated with adjuvant therapy. The alternative hypothesis is that the postoperative complication rate differs between these two arms.
    End point type
    Primary
    End point timeframe
    up to the 30th postoperative day or the day of discharge from hospital.
    End point values
    Arm A Arm B ITT Analysis
    Number of subjects analysed
    11
    13
    24
    Units: Clavien score > grade 1
    11
    13
    24
    Statistical analysis title
    two sided Cochran-Mantel-Haenszel (CMH) test
    Statistical analysis description
    Postoperative complications grade > 1 in both treatment arms were compared using the two sided Cochran-Mantel-Haenszel (CMH) test stratified for Fong Score, tumour volume and Study Site at a two-sided significance level of 0.05. The primary analysis for the post-operative complication rate was performed in all patients with surgery for liver resection. An intention-to-treat analysis was also planned in all randomized patients.
    Comparison groups
    Arm A v Arm B v ITT Analysis
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [1]
    P-value
    < 0.05
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Cox proportional hazard
    Point estimate
    0.14208
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.078
         upper limit
    17.008
    Variability estimate
    Standard error of the mean
    Notes
    [1] - The following two null hypotheses will be tested confirmatory in hierarchical order, so that no alpha adjustment is necessary. The null hypothesis is that the postoperative complication rate (≥ grade I according Dindo et.al.) is equal between the arm treated with perioperative therapy and the arm treated with adjuvant therapy. The alternative hypothesis is that the postoperative complication rate differs between these two arms.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs will be entered in the case report form. Sponsor must be informed within 24 h of SAEs/ significant side effects/ deaths.
    Adverse event reporting additional description
    The Investigator will collect adverse events by asking the subject a general question (“how did you feel since last visit”). Also, the Investigator will ask the subject whether (s)he has experienced any symptoms or discomfort since the last visit (non-leading question).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    A total of 314 adverse events (AEs) occurred in 19 patients, who received chemotherapy in both arms (Listing 14, section 13.2.6). 90 AEs occurred in Arm A and 224 in Arm B. 6 of the 19 patients showed SAEs, 4 in Arm A and 2 in Arm B (Table 16).

    Reporting group title
    Arm B
    Reporting group description
    A total of 314 adverse events (AEs) occurred in 19 patients, who received chemotherapy in both arms (Listing 14, section 13.2.6). 90 AEs occurred in Arm A and 224 in Arm B. 6 of the 19 patients showed SAEs, 4 in Arm A and 2 in Arm B (Table 16).

    Serious adverse events
    Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    2 / 13 (15.38%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (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
    Hypoxia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 11 (63.64%)
    12 / 13 (92.31%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Vascular disorders - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Visceral arterial ischemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Edema trunk
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    3
    Fever
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    General disorders and administration site conditions - Other
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hematoma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Palmar-plantar erythrodysesthesia syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Hoarseness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Pneumothorax
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Aphonia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Delirium
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hallucinations
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Investigations
    Investigations - Other
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Cardiac disorders
    Cardiac disorders - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Chest pain - cardiac
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Paresthesia
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 13 (30.77%)
         occurrences all number
    1
    4
    Vertigo
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Anorexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders - Other
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Febrile neutropenia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 13 (23.08%)
         occurrences all number
    1
    3
    Platelet count decreased
         subjects affected / exposed
    3 / 11 (27.27%)
    3 / 13 (23.08%)
         occurrences all number
    3
    3
    Thromboembolic event
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    White blood cell decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 13 (23.08%)
         occurrences all number
    2
    3
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 13 (23.08%)
         occurrences all number
    1
    3
    Dehydration
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Diarrhea
         subjects affected / exposed
    4 / 11 (36.36%)
    5 / 13 (38.46%)
         occurrences all number
    4
    5
    Gastrointestinal disorders - Other
         subjects affected / exposed
    3 / 11 (27.27%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Nausea
         subjects affected / exposed
    3 / 11 (27.27%)
    6 / 13 (46.15%)
         occurrences all number
    3
    6
    Rectal obstruction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Biliary anastomotic leak
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    GGT increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hepatic hemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hepatobiliary disorders - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    3
    Bruising
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Papulopustular rash
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Rash acneiform
         subjects affected / exposed
    4 / 11 (36.36%)
    9 / 13 (69.23%)
         occurrences all number
    4
    9
    Rash maculo-papular
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 13 (30.77%)
         occurrences all number
    1
    4
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Prostatic obstruction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Bone marrow hypocellular
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gynecomastia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Breast infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Bronchial infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gum infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations - Other
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Lung infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Mucositis oral
         subjects affected / exposed
    3 / 11 (27.27%)
    5 / 13 (38.46%)
         occurrences all number
    3
    5
    Wound infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hyperkalemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hypocalcemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Hypokalemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 13 (7.69%)
         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
    26 Jan 2015
    10.3 Definition of the end of study According to the Amendment No. 1, the end of study is defined as the date of the approval of the German or Austrian Competent Authority or the positive opinion of the German or Austrian Ethics Committee for the Amendment No. 1, whatever is dated the latest

    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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    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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