Study Stopped
Due to strategic company decisions, the development of anetumab ravtansine was stopped.
A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
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
2 other identifiers
interventional
9
4 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2019
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2022
CompletedResults Posted
Study results publicly available
August 4, 2023
CompletedAugust 4, 2023
July 1, 2023
3 years
April 23, 2019
April 28, 2023
July 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Overall Survival
Approximately 3 years (from first study treatment until safety follow-up)
Study Arms (1)
Cancer patients
EXPERIMENTALAdult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study
Interventions
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (7)
University of Chicago
Chicago, Illinois, 60637, United States
National Cancer Institute - Maryland
Bethesda, Maryland, 20892, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75230, United States
Hôpital de la Timone - Marseille
Marseille, 13385, France
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162, Italy
Samodzielny Publiczny Wojewodzki Szpital Zespolony
Szczecin-Zdunowo, 70-891, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the small sample size and heterogeneous population, survival distributions and the extent of long-term survival in the applicable populations cannot be reliably estimated from the study results. Overall results were reported. Pooling was done because there is only a single patient treated with combination and no summary tables on a single patient.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 24, 2019
Study Start
June 3, 2019
Primary Completion
May 18, 2022
Study Completion
May 18, 2022
Last Updated
August 4, 2023
Results First Posted
August 4, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later 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.vivli.org 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 member section of the portal.