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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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03926143
Collaborator
(none)
9
Enrollment
7
Locations
1
Arm
35.5
Actual Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Drug: BAY94-9343 (Anetumab ravtansine)
 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
Actual Enrollment :
9 participants
Allocation:
N/A
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 :
Jun 3, 2019
Actual Primary Completion Date :
May 18, 2022
Actual Study Completion Date :
May 18, 2022

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
Other Names:
  • Anti-mesothelin antibody, Maytansinoid tubulin inhibitor DM4

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) [Up to 5.5 years]

    2. Incidence of treatment-emergent serious adverse events (TESAEs) [Up to 5.5 years]

    3. Incidence of drug-related TEAEs [Up to 5.5 years]

    4. Incidence of drug-related TESAEs [Up to 5.5 years]

    Secondary Outcome Measures

    1. Overall survival [Up to 5.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637
    2 National Cancer Institute - Maryland Bethesda Maryland United States 20892
    3 Sarah Cannon Cancer Center Nashville Tennessee United States 37203
    4 Mary Crowley Medical Research Center Dallas Texas United States 75230
    5 Hôpital de la Timone - Marseille Marseille France 13385
    6 ASST Grande Ospedale Metropolitano Niguarda Milano Lombardia Italy 20162
    7 Szpital Wojewodzki W Szczecinie Zdunowie Szczecin Poland 70-891

    Sponsors and Collaborators

    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT03926143
    Other Study ID Numbers:
    • 20322
    • 2019-000061-20
    First Posted:
    Apr 24, 2019
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Maytansine
    Tubulin Modulators

    Study Results

    No Results Posted as of Jun 10, 2022