stop_circleTerminated/Withdrawn

Solid tumors

Bayer Identifier:

20322

ClinicalTrials.gov Identifier:

NCT03926143

EudraCT Number:

2019-000061-20

EU CT Number:

Not Available
A clinical study of anetumab ravtansine in adults with solid tumors who have been treated in previous Bayer-sponsored anetumab ravtansine studies

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
9
Trial Dates
June 2019 - May 2022
Phase
Phase 2
Could I Receive a placebo
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Samodzielny Publiczny Wojewodzki Szpital ZespolonySzczecin-Zdunowo, 70-891, Poland
Withdrawn
Centre Georges Francois Leclerc DijonDIJON, 21079, France
Completed
Hôpital de la Timone - MarseilleMarseille, 13385, France
Withdrawn
Fondazione IRCCS Istituto Nazionale dei TumoriMilano, 20133, Italy
Completed
Sarah Cannon Cancer CenterNashville, 37203, United States
Completed
Mary Crowley Medical Research CenterDallas, 75230, United States
Withdrawn
Univ.of California-San Diego Moores Cancer CenterLa Jolla, 92093, United States
Completed
National Cancer Institute - MarylandBethesda, 20892, United States
Withdrawn
Medical University of South Carolina Medical CenterCharleston, 29425, United States
Completed
University of ChicagoChicago, 60637, United States
Completed
ASST Grande Ospedale Metropolitano NiguardaMilano, 20162, Italy

Primary Outcome

  • Number of participants with TEAEs, TESAEs and Drug-related TEAEs and TESAEs
    Treatment emergent adverse events (TEAEs) were defined as AEs starting or worsening during the treatment period. The treatment period extended from the first date of study treatment in this study until the safety follow-up (30 days after the last administration of study treatment). TESAEs: Treatment emergent serious adverse events.
    date_rangeTime Frame:
    Approximately 3 years (from first study treatment until safety follow-up)

Secondary Outcome

  • Overall survival
    Overall survival (OS) defined as the time from first treatment in this study until death from any cause. Data on survival were collected by the site. Time frame was reduced due to early termination of the study. Table reports Kaplan-Meier median with Brookmeyer-Crowley confidence intervals. Number (%) of participants with event: 5 (55.6%) and Number (%) of participants censored: 4 (44.4%).
    date_rangeTime Frame:
    Approximately 3 years (from first study treatment until safety follow-up)

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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