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

  • Clinicaltrials.gov identifier

    NCT03926143

  • Recruitment Status

    Enrolling by invitation

  • First Posted

    April 24, 2019

  • Last update posted

    May 25, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Cancer
  • Intervention/Treatment: Drug: BAY94-9343 (Anetumab ravtansine)
  • Phase: Phase 2

Detailed 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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: October 2024
  • Estimated Study Completion Date: October 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Cancer patients
Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study
Drug: BAY94-9343 (Anetumab ravtansine)
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies

Outcome Measures

  • 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 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Locations

United States, Illinois
University of Chicago
Chicago

United States, Maryland
National Cancer Institute
Bethesda

United States, Tennessee
Sarah Cannon Research Institute
Nashville

United States, Texas
Mary Crowley Medical Research Center
Dallas

France
Hôpital de la Timone - Marseille
Marseille

Italy, Lombardia
ASST Grande Ospedale Metropolitano Niguarda
Milano

Poland
Szpital Wojewodzki W Szczecinie Zdunowie
Szczecin

Sponsors and Collaborators

Bayer

More Information

  • Responsible Party: Bayer
  • ClinicalTrials.gov Identifier: NCT03926143 History of Changes
  • Other Study ID Numbers: 20322, 2019-000061-20
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: May 25, 2021
  • Last Verified: May 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bayer: Solid tumors
    Mesothelin
    Mesothelioma