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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02610140
Registration number
NCT02610140
Ethics application status
Date submitted
9/11/2015
Date registered
20/11/2015
Date last updated
4/11/2020
Titles & IDs
Public title
Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
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Scientific title
A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy
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Secondary ID [1]
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2012-003650-88
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Secondary ID [2]
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15743
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mesothelioma
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Anetumab ravtansine (BAY94-9343)
Treatment: Drugs - Vinorelbine
Experimental: BAY94-9343 - Drug Anetumab ravtansine given Intravenously (IV)
Active Comparator: Vinorelbine - Drug Vinorelbine given Intravenously
Treatment: Drugs: Anetumab ravtansine (BAY94-9343)
Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
Treatment: Drugs: Vinorelbine
Starting dose: 30mg/m^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS), [95% CI]
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Assessment method [1]
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Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
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Timepoint [1]
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From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)
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Secondary outcome [1]
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Overall Survival (OS), [95% CI]
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Assessment method [1]
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Overall survival (OS) was defined as time from randomization until death from any cause.
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Timepoint [1]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
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Timepoint [2]
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up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients.
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Timepoint [3]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
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Secondary outcome [4]
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Duration of Response (DOR)
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Assessment method [4]
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DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
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Timepoint [4]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
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Secondary outcome [5]
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Durable Response Rate (DRR)
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Assessment method [5]
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A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more.
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Timepoint [5]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
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Secondary outcome [6]
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Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
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Assessment method [6]
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Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma.
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Timepoint [6]
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up to approx. 30 months (data cut-off: 31-May-2017)
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Secondary outcome [7]
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Time to Worsening of Symptoms Characteristic of Mesothelioma
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Assessment method [7]
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Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS.
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Timepoint [7]
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up to approx. 30 months (data cut-off: 31-May-2017)
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Secondary outcome [8]
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Time to Worsening of Pain
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Assessment method [8]
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Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score.
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Timepoint [8]
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up to approx. 30 months (data cut-off: 31-May-2017)
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Secondary outcome [9]
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Percentage of Participants With Confirmed Improvement of Pain
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Assessment method [9]
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Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain.
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Timepoint [9]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
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Secondary outcome [10]
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Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [10]
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TEAEs were defined as all AEs starting or worsening within the treatment period.
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Timepoint [10]
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Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).
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Secondary outcome [11]
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Number of Deaths
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Assessment method [11]
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TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018.
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Timepoint [11]
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Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
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Secondary outcome [12]
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Overall Survival (OS) - Addendum
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Assessment method [12]
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Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019.
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Timepoint [12]
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Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause
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Eligibility
Key inclusion criteria
- Histological documentation of malignant pleural mesothelioma (MPM) overexpressing
mesothelin
- Unresectable locally advanced or metastatic MPM after locally confirmed progression on
1st line treatment with platinum in combination with pemetrexed.
- Patients must have measurable disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver and renal function
- Left ventricular ejection fraction (LVEF) = 50% or the lower limit of normal (LLN)
according to local institution ranges of normality.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- More than 1 previous systemic anti-cancer therapy line
- Patients with corneal epitheliopathy or any eye disorder that may predispose the
patients to this condition at the discretion of the investigator in consultation with
the ophthalmologist.
- Brain metastases, meningeal tumours or other metastases in the central nervous system
- Evidence of history of bleeding diathesis.
- Ongoing or active infection (bacterial, fungal, or viral) of National Cancer
Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03
Grade > 2.
- Pre-existing cardiac conditions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/09/2019
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Sample size
Target
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Accrual to date
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Final
248
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- St Leonards
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Recruitment hospital [2]
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- Woolloogabba
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Recruitment hospital [3]
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- Adelaide
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Recruitment hospital [4]
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- Richmond
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Recruitment hospital [5]
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- Nedlands
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4102 - Woolloogabba
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Recruitment postcode(s) [3]
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5043 - Adelaide
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Recruitment postcode(s) [4]
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3122 - Richmond
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Texas
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Belgium
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Bruxelles - Brussel
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Belgium
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Edegem
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Belgium
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Gent
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Leuven
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Ontario
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Helsinki
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Vaasa
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Bordeaux Cedex
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France
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France
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France
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Paris
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France
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Pierre Benite
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Friuli-Venezia Giulia
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Piemonte
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Toscana
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Korea, Republic of
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Gdansk
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Krakow
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Szczecin
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Russian Federation
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Omsk
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Russian Federation
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Yekaterinburg
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A Coruña
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Spain
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Alicante
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Spain
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Barcelona
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Madrid
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Adana
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Ankara
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Malatya
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Turkey
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Yenimahalle
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United Kingdom
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Devon
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United Kingdom
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Kent
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United Kingdom
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Leicestershire
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Glasgow
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London
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Manchester
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United Kingdom
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Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Other
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Name [1]
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ImmunoGen and MorphoSys
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine
versus vinorelbine in progression free survival in patients with stage IV mesothelin
overexpressing malignant pleural mesothelioma (MPM).
210 eligible patients will be randomized to receive either anetumab ravtansine every three
weeks or weekly vinorelbine.
Treatment will continue until centrally confirmed disease progression or until another
criterion is met for withdrawal from the study. Patients will enter follow up phase to
capture safety and endpoint data as required.
Efficacy will be measured by evaluating progression free survival from randomization.
Radiological tumor assessments will be performed at defined time points until the patient's
disease progresses.
Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival
or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02610140
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02610140
Download to PDF