check_circleStudy Completed
Mesothelioma
Bayer Identifier:
15743
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
248Trial Dates
December 2015 - September 2019Phase
Phase 2Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | EDEGEM, 2650, Belgium | |
Completed | Torino, 10043, Italy | |
Withdrawn | Heidelberg, 69126, Germany | |
Withdrawn | Grosshansdorf, 22927, Germany | |
Completed | Bergamo, 24125, Italy | |
Completed | Monza Brianza, 20900, Italy | |
Completed | Pordenone, 33081, Italy | |
Completed | Siena, 53100, Italy | |
Completed | Milano, 20089, Italy | |
Withdrawn | Essen, 45122, Germany | |
Withdrawn | Bochum, 44791, Germany | |
Withdrawn | Berlin, 13125, Germany | |
Completed | Toronto, M5G 2M9, Canada | |
Completed | Bethesda, 20814, United States | |
Completed | Dallas, 75251, United States | |
Completed | New Orleans, 70121, United States | |
Completed | Aurora, 80045, United States | |
Completed | Chicago, 60637, United States | |
Completed | Nedlands, 6009, Australia | |
Completed | Woolloogabba, 4102, Australia | |
Withdrawn | Ann Arbor, 48106, United States | |
Completed | London, SE1 9RT, United Kingdom | |
Completed | Adelaide, 5043, Australia | |
Completed | Barcelona, 08035, Spain | |
Completed | Madrid, 28041, Spain | |
Withdrawn | Badalona (Barcelona), 08916, Spain | |
Completed | A Coruña, 15006, Spain | |
Completed | Richmond, 3122, Australia | |
Withdrawn | Heidelberg, 3084, Australia | |
Completed | Calgary, T2N 4N2, Canada | |
Completed | Hamilton, L8V 5C2, Canada | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Leicester, LE1 5WW, United Kingdom | |
Completed | Plymouth, PL6 8DH, United Kingdom | |
Completed | Newcastle Upon Tyne, NE7 7DN, United Kingdom | |
Completed | Manchester, M23 9LT, United Kingdom | |
Completed | Gdansk, 80-952, Poland | |
Completed | Szczecin, 70-891, Poland | |
Completed | Alicante, 03010, Spain | |
Completed | ROTTERDAM, 3015 CE, Netherlands | |
Completed | AMSTERDAM, 1066 CX, Netherlands | |
Completed | St Leonards, 2065, Australia | |
Completed | Ankara, 06100, Turkey | |
Completed | Vaasa, 65130, Finland | |
Completed | Helsinki, 00290, Finland | |
Completed | Turku, 20520, Finland | |
Withdrawn | San Francisco, 94115, United States | |
Completed | Malatya, 44280, Turkey | |
Completed | Istanbul, 34899, Turkey | |
Completed | Adana, 01330, Turkey | |
Completed | Yenimahalle, 06200, Turkey | |
Completed | Tampa, 33612, United States | |
Completed | Norwich, 06360, United States | |
Completed | La Jolla, 92093-1503, United States | |
Completed | Lille Cedex, 59037, France | |
Completed | PIERRE BENITE, 69495, France | |
Withdrawn | TOULOUSE CEDEX 9, 31059, France | |
Terminated | BORDEAUX CEDEX, 33076, France | |
Withdrawn | VILLEJUIF CEDEX, 94805, France | |
Withdrawn | TOURS, 37044, France | |
Completed | PARIS, 75020, France | |
Completed | Krakow, 31-202, Poland | |
Completed | Krakow, 31-501, Poland | |
Completed | Cleveland, 44195, United States | |
Completed | LEUVEN, 3000, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | LIEGE, 4000, Belgium | |
Completed | Chicago, 60612, United States | |
Completed | Buffalo, 14263-0001, United States | |
Terminated | New York, 10016, United States | |
Completed | Houston, 77030, United States | |
Completed | Rochester, 55905, United States | |
Completed | Houston, 77030, United States | |
Completed | Yekaterinburg, 620036, Russian Federation | |
Completed | Omsk, 644013, Russian Federation | |
Withdrawn | Philadelphia, 19104, United States | |
Completed | London, N6A 4L6, Canada | |
Completed | Durham, 27710, United States | |
Completed | MARSEILLE, 13915, France | |
Withdrawn | Madrid, 28034, Spain | |
Withdrawn | Valencia, 46014, Spain | |
Completed | Málaga, 29010, Spain | |
Withdrawn | Tampere, 33521, Finland | |
Withdrawn | Helsinki, 00180, Finland | |
Completed | Milano, 20133, Italy | |
Withdrawn | Padova, 35128, Italy | |
Withdrawn | Lecce, 73100, Italy | |
Withdrawn | Mechelen, 2800, Belgium | |
Completed | SINT-NIKLAAS, 9100, Belgium | |
Withdrawn | Baltimore, 21201, United States | |
Completed | Maidstone, ME16 9QQ, United Kingdom | |
Completed | Glasgow, G12 0YN, United Kingdom | |
Withdrawn | Istanbul, 34098, Turkey | |
Completed | Eskisehir, 26480, Turkey | |
Withdrawn | Minneapolis, 55455, United States | |
Completed | CAEN CEDEX 5, 14076, France | |
Terminated | PARIS, 75018, France |
Primary Outcome
- Progression Free SurvivalDefined as time from randomization until disease progression or death. Patients not experiencing death or progression will be censored at the last tumor assessment.date_rangeTime Frame:Approx. 22 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall survival (OS)Defined as time from randomization until death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored at the last known alive date.date_rangeTime Frame:Approx. 42 monthsenhanced_encryptionNoSafety Issue:
- Improvement of symptoms characteristic of mesotheliomaImprovement occurs if best change from baseline in total subset score per the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) meets improvement criteria. Improvement must be confirmed by a second MDASI-MPM assessment.date_rangeTime Frame:Approx. 22 months
- Improvement of painImprovement occurs if best change from baseline in pain score per the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma (MDASI-MPM) meets improvement criteria. Improvement must be confirmed by a second MDASI-MPM assessment.date_rangeTime Frame:Approx. 22 months
- Objective responseA patient is a responder if the patient’s best confirmed tumor response on-study of (complete response) CR or PR, as determined by the central radiological reviewer per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria for MPM.date_rangeTime Frame:Approx. 22 months
- Duration of response (DOR)Defined in responders as time from first documentation of tumor response (CR or PR) per mRECIST criteria to disease progression or death, as determined by central radiological reviewer.date_rangeTime Frame:Approx. 42 months
- Treatment emergent adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Approx. 22 months
- Serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Approx. 22 months
- Disease controlA patient experiences disease control if the patient’s best response on-study confirmed tumor response of CR or PR or a tumor response of SD, as determined by the central radiological reviewer per mRECIST criteriadate_rangeTime Frame:Approx. 22 months
- Durable ResponseA patient experiences durable response if the patient is Defined in responders as a responder with a duration of response of 180 days or more as determined by the central radiological reviewer.date_rangeTime Frame:Approx. 42 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2