A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies

Study Overview
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Brief Summary
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The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

Detailed Description
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The primary objective of the study is to collect long-term safety information on anetumab ravtansine and to enable patients, who received an anetumab ravtansine-containing treatment in any Bayer-sponsored anetumab ravtansine parent study, to continue the treatment. The secondary objective is to further investigate the efficacy of the drug.

Official Title
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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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: BAY94-9343 (Anetumab ravtansine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. For applicable studies: should treatment be permanently interrupted in the parent study, participants may be enrolled in the follow-up portion of the rollover study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer patients<br>Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study | Drug: BAY94-9343 (Anetumab ravtansine)<br>* BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies<br>* Other names: Anti-mesothelin antibody, Maytansinoid tubulin inhibitor DM4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs | Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events. | Approximately 3 years (from first study treatment until safety follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%). | Approximately 3 years (from first study treatment until safety follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, Mesothelin, Mesothelioma