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

  • Interventional
  • Recruiting
  • NCT03926143
Eligibility Details Visit Clinicaltrials.gov

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.

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

        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.

At a Glance

National Government IDNCT03926143

IRB#IRB19-0379

Lead SponsorBayer

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting