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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03926143
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Cancer 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.

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Study Type : Interventional  (Clinical Trial)
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.
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


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 Name: Anti-mesothelin antibody, Maytansinoid tubulin inhibitor DM4




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926143


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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United States, California
Univ.of California-San Diego Moores Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
National Cancer Institute Not yet recruiting
Bethesda, Maryland, United States, 20892
United States, South Carolina
Medical University of South Carolina Medical Center Not yet recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Sarah Cannon Research Institute Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Medical Research Center Not yet recruiting
Dallas, Texas, United States, 75230
France
Centre Georges Francois Leclerc Dijon Not yet recruiting
Dijon, France, 21000
Hôpital de la Timone - Marseille Not yet recruiting
Marseille, France, 13385
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milano, Lombardia, Italy, 20133
Poland
Szpital Wojewodzki W Szczecinie Zdunowie Not yet recruiting
Szczecin, Poland, 70-891
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03926143     History of Changes
Other Study ID Numbers: 20322
2019-000061-20 ( EudraCT Number )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
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.


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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:
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Maytansine
Immunoconjugates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs