stop_circleTerminated/Withdrawn
Solid tumors
Bayer Identifier:
20322
ClinicalTrials.gov Identifier:
EudraCT Number:
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
AllAge
18 - N/ATrial summary
Enrollment Goal
9Trial Dates
June 2019 - May 2022Phase
Phase 2Could I Receive a placebo
NoProducts
Anetumab ravtansine (BAY94-9343)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Samodzielny Publiczny Wojewodzki Szpital Zespolony | Szczecin-Zdunowo, 70-891, Poland |
Withdrawn | Centre Georges Francois Leclerc Dijon | DIJON, 21079, France |
Completed | Hôpital de la Timone - Marseille | Marseille, 13385, France |
Withdrawn | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy |
Completed | Sarah Cannon Cancer Center | Nashville, 37203, United States |
Completed | Mary Crowley Medical Research Center | Dallas, 75230, United States |
Withdrawn | Univ.of California-San Diego Moores Cancer Center | La Jolla, 92093, United States |
Completed | National Cancer Institute - Maryland | Bethesda, 20892, United States |
Withdrawn | Medical University of South Carolina Medical Center | Charleston, 29425, United States |
Completed | University of Chicago | Chicago, 60637, United States |
Completed | ASST Grande Ospedale Metropolitano Niguarda | Milano, 20162, Italy |
Primary Outcome
- Number of participants with TEAEs, TESAEs and Drug-related TEAEs and TESAEsTreatment 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 survivalOverall 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1