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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
University of Chicago
Chicago, Illinois, United States
National Cancer Institute - Maryland
Bethesda, Maryland, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
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.
Time frame: Approximately 3 years (from first study treatment until safety follow-up)
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%).
Time frame: Approximately 3 years (from first study treatment until safety follow-up)
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Hôpital de la Timone - Marseille
Marseille, France
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Samodzielny Publiczny Wojewodzki Szpital Zespolony
Szczecin-Zdunowo, Poland