NCT03926143 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2023-08-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Adult patients with solid cancer who received anetumab-ravtansine treatment in a completed Bayer study
intervention Names
Drug: BAY94-9343 (Anetumab ravtansine)
label
Cancer patients
type
EXPERIMENTAL

interventions

arm Group Labels
Cancer patients
description
BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
name
BAY94-9343 (Anetumab ravtansine)
other Names
Anti-mesothelin antibody, Maytansinoid tubulin inhibitor DM4
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 9
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants With TEAEs, TESAEs and Drug-related TEAEs and TESAEs
time Frame
Approximately 3 years (from first study treatment until safety follow-up)

secondary Outcomes

description
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%).
measure
Overall Survival
time Frame
Approximately 3 years (from first study treatment until safety follow-up)

Full study description

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.

Source references