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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03102320
Registration number
NCT03102320
Ethics application status
Date submitted
30/03/2017
Date registered
5/04/2017
Titles & IDs
Public title
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
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Scientific title
Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
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Secondary ID [1]
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2016-004002-33
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Secondary ID [2]
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15834
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Universal Trial Number (UTN)
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Trial acronym
ARCS-Multi
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Anetumab ravtansine (BAY94-9343)
Experimental: Cholangiocarcinoma - Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin. Please note the study is no longer recruiting for the cholangiocarcinoma safety lead-in phase.
During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin. Please note the main study phase for cholangiocarcinoma will no longer be going ahead.
Experimental: Adenocarcinoma of the pancreas - Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine
Experimental: Other solid tumors - (Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast - triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors
Treatment: Drugs: Cisplatin
Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
Treatment: Drugs: Gemcitabine
Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
Treatment: Drugs: Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
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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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Number of patients in the safety lead-in (SLI) phase who completed Cycle 1 or had a DLT and were not replaced.
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Assessment method [1]
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During SLI, patients with cholangiocarcinoma received anetumab ravtansine in combination with cisplatin and patients with pancreatic adenocarcinoma received anetumab ravtansine in combination with gemcitabine. The highest dose of anetumab ravtansine that can be given so that not more than 1 out of 6 patients experiences a dose-limiting toxicity (DLT) during the DLT evaluation period were declared as the MTD for anetumab ravtansine in combination with cisplatin or with gemcitabine.
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Timepoint [1]
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At least 3 weeks after the last patient starts treatment
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Primary outcome [2]
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Objective response (qualitative improvement from baseline) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumors
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Assessment method [2]
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A patient is a responder if the patient has a best response compared to baseline of complete response (CR) or partial response (PR) among all post-baseline tumor assessments, as determined per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma)
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Timepoint [2]
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Up to approximately 26 months after patient starts treatment
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Primary outcome [3]
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Durable disease control (lack of progression from baseline) of anetumab ravtansine in indications pancreatic and gastric cancer (co-primary endpoint)
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Assessment method [3]
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A patient experiences durable disease control if the patient has a tumor response compared to baseline of CR, PR or stable disease (SD) among the post-baseline tumor assessments made at least 180 days from first treatment, without prior disease progression
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Timepoint [3]
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Up to approximately 26 months after patient starts treatment
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Secondary outcome [1]
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Number of serious and non-serious adverse events (AEs)
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Assessment method [1]
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Include treatment-emergent AEs, SAEs, treatment-related AEs, AEs of special interest, and deaths.
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Timepoint [1]
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Approximately 26 months (Until 30 days after the last day of study treatment, or until later resolution of adverse events or determination by the investigator that the event will not improve)
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Secondary outcome [2]
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Disease control rate (DCR)
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Assessment method [2]
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The DCR is defined as the number of patients with disease control divided by the number of treated patients.
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Timepoint [2]
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Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
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Secondary outcome [3]
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Duration of response (DOR)
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Assessment method [3]
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DOR is defined in responders as the time from documentation of tumor response (CR or PR) to earlier of disease progression or death
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Timepoint [3]
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Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
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Secondary outcome [4]
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Durable response rate (DRR)
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Assessment method [4]
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A durable responder is defined as a responder (CR or PR) with a duration of response per RECIST 1.1 criteria (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) of 180 days or more. The DRR is the number of durable responders divided by the number of treated patients.
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Timepoint [4]
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Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
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Secondary outcome [5]
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Progression free survival (PFS)
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Assessment method [5]
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PFS is defined as time from start of treatment until disease progression according to RECIST 1.1 (ITMIG modified RECIST 1.1 criteria for thymic carcinoma) or death.
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Timepoint [5]
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Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
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Secondary outcome [6]
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Durable disease control rate (DDCR) of anetumab ravtansine in indications other than pancreatic and gastric cancer
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Assessment method [6]
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A patient experiences durable disease control if the patient has a tumor response of CR, PR or SD with CR, PR or SD assessed at least 180 days from first treatment, without prior progression.
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Timepoint [6]
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Up to approximately 24 months after last patient starts treatment, or until earlier disease progression [assessed every 6 weeks for the first 6 months, every 9 weeks until end of year 1 and every 12 weeks thereafter]
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Eligibility
Key inclusion criteria
* Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis
* Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria
* Adequate bone marrow, liver, renal and coagulation function
* Left ventricular ejection fraction (LVEF) = 50% of the lower limit of normal (LLN) according to local institutional ranges
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
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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
* Exposure to more than one prior anti-tubulin/microtubule agent
* Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
* Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
* Contraindication to both CT and MRI contrast agents
* Active hepatitis B or C infection
* Pregnant or breast-feeding patients
* Tumor type specific exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 1
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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
26/05/2017
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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
26/07/2021
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Sample size
Target
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Accrual to date
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Final
173
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Cancer & Haematology Centre - Blacktown
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Recruitment hospital [2]
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Mid North Coast Cancer Institute - Coffs Harbour
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Recruitment hospital [3]
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Kinghorn Cancer Centre - Darlinghurst
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Recruitment hospital [4]
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Northern Cancer Institute - St Leonards
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Recruitment hospital [5]
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Flinders Medical Centre - Adelaide
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Recruitment hospital [6]
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Epworth HealthCare - Richmond
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [8]
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St John of God Healthcare - Subiaco
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Recruitment postcode(s) [1]
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2148 - Blacktown
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2450 - Coffs Harbour
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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2065 - St Leonards
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Recruitment postcode(s) [5]
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5042 - Adelaide
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Recruitment postcode(s) [6]
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3122 - Richmond
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment postcode(s) [8]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Indiana
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Louisiana
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Leicestershire
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Manchester
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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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Commercial sector/industry
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Name [1]
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ImmunoGen, Inc.
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Commercial sector/industry
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Name [2]
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MorphoSys AG
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Ethics approval
Ethics application status
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Summary
Brief summary
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. 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 will also be collected for mesothelin expression testing and biomarker analyses.
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Trial website
https://clinicaltrials.gov/study/NCT03102320
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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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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03102320