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.

Primary Outcome Measures

  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5.5 years ]
  2. Incidence of treatment-emergent serious adverse events (TESAEs) [ Time Frame: Up to 5.5 years ]
  3. Incidence of drug-related TEAEs [ Time Frame: Up to 5.5 years ]
  4. Incidence of drug-related TESAEs [ Time Frame: Up to 5.5 years ]

Secondary Outcome Measures

  1. Overall survival [ Time Frame: Up to 5.5 years ]

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.

« Mesothelioma Clinical Trials Main Page.

Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: September 20th, 2019.

You can follow any responses to this entry through the RSS 2.0 feed.

Both comments and pings are currently closed.

Comments are closed.

Last update: May 07, 2019. 08:38:48 pm.