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

20322

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.

2019-06-03

2022-05-18

2022-05-18

Terminated

Early phase I

9

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

2023-08-04