Trial Condition(s):
Solid tumors
A clinical study of anetumab ravtansine in adults with solid tumors who have been treated in previous Bayer-sponsored anetumab ravtansine studies
Bayer Identifier:
20322
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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.Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Samodzielny Publiczny Wojewodzki Szpital Zespolony Szczecin-Zdunowo, Poland, 70-891 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Timone - Marseille Marseille, France, 13385 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sarah Cannon Cancer Center Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mary Crowley Medical Research Center Dallas, United States, 75230 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Cancer Institute - Maryland Bethesda, United States, 20892 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Chicago Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Grande Ospedale Metropolitano Niguarda Milano, Italy, 20162 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
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.Timeframe: 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%).Timeframe: Approximately 3 years (from first study treatment until safety follow-up)
Additional Information
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