A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03926143|
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : June 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: BAY94-9343 (Anetumab ravtansine)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 3, 2019|
|Actual Primary Completion Date :||May 18, 2022|
|Actual Study Completion Date :||May 18, 2022|
Experimental: Cancer patients
Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study
Drug: BAY94-9343 (Anetumab ravtansine)
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
Other Name: Anti-mesothelin antibody, Maytansinoid tubulin inhibitor DM4
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5.5 years ]
- Incidence of treatment-emergent serious adverse events (TESAEs) [ Time Frame: Up to 5.5 years ]
- Incidence of drug-related TEAEs [ Time Frame: Up to 5.5 years ]
- Incidence of drug-related TESAEs [ Time Frame: Up to 5.5 years ]
- Overall survival [ Time Frame: Up to 5.5 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Participants ongoing in an applicable Bayer-sponsored anetumab ravtansine parent study at the time of its planned study closure.
- For on-treatment participants: participant is eligible to receive the next dose of study intervention per the parent study protocol.
- For on-treatment participants: a positive serum pregnancy test.
- For on-treatment participants: use of one or more of the prohibited medications listed in the respective parent study protocol.
- Participants who are receiving standard-of-care agent(s) but not anetumab ravtansine in the parent study, and are able to receive standard-of-care agent outside of the clinical study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926143
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|National Cancer Institute - Maryland|
|Bethesda, Maryland, United States, 20892|
|United States, Tennessee|
|Sarah Cannon Cancer Center|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Mary Crowley Medical Research Center|
|Dallas, Texas, United States, 75230|
|Hôpital de la Timone - Marseille|
|Marseille, France, 13385|
|ASST Grande Ospedale Metropolitano Niguarda|
|Milano, Lombardia, Italy, 20162|
|Szpital Wojewodzki W Szczecinie Zdunowie|
|Szczecin, Poland, 70-891|
|Other Study ID Numbers:||
2019-000061-20 ( EudraCT Number )
|First Posted:||April 24, 2019 Key Record Dates|
|Last Update Posted:||June 10, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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.
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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