A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
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.
- Added: September 20th, 2019.
- Last updated: September 20th, 2019.
Primary Outcome Measures
- 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 ]
Secondary Outcome Measures
- Overall survival [ Time Frame: Up to 5.5 years ]
- 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.
Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: September 20th, 2019.
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