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

Bayer

Status and phase

Terminated

Phase 2

Conditions

Solid Tumors

Treatments

Drug: BAY94-9343 (Anetumab ravtansine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03926143

20322

2019-000061-20 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.