Clinical trial NCT03926143: A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumors
Keywords: Solid tumors
Mesothelin
Mesothelioma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.
* 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.

Primary outcomes:
measure: Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
timeFrame: Approximately 3 years (from first study treatment until safety follow-up)
Secondary outcomes:
measure: Overall Survival
timeFrame: Approximately 3 years (from first study treatment until safety follow-up)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Bethesda
country: United States
facility: National Cancer Institute - Maryland
state: Maryland
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Marseille
country: France
facility: Hôpital de la Timone - Marseille
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Szczecin-Zdunowo
country: Poland
facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony
Study officials:
References: