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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03926143
• Other study ID #: 20322
• Secondary ID: 2019-000061-20
• Status: Terminated
• Phase: Phase 2
• Start date: June 3, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 18, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.
• 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.

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• BAY94-9343 (Anetumab ravtansine)
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies

Locations

Country	Name	City	State
France	Hôpital de la Timone - Marseille	Marseille
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	Lombardia
Poland	Samodzielny Publiczny Wojewodzki Szpital Zespolony	Szczecin-Zdunowo
United States	National Cancer Institute - Maryland	Bethesda	Maryland
United States	University of Chicago	Chicago	Illinois
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Sarah Cannon Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  France,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 3 years (from first study treatment until safety follow-up)
Secondary	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%).	Approximately 3 years (from first study treatment until safety follow-up)

External Links

•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe
•   Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.