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NCT02610140 · ClinicalTrials.gov registry record · Phase 2
Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
NCT02610140 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 248 participants.
The verdict
NCT02610140, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
Study Summary
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required. Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
Interventions
- DRUG Vinorelbine
- DRUG Anetumab ravtansine (BAY94-9343)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2015-12-03 |
| Est. Completion | 2019-09-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02610140
The ClinicalTrials.gov registry entry for NCT02610140 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vinorelbine is the first listed.
NCT02610140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02610140 about?
NCT02610140 is a clinical study titled "Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)". The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab r...
What is the current status of trial NCT02610140?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2015-12-03. Estimated completion is 2019-09-06.
What interventions are being tested in trial NCT02610140?
The interventions under investigation include: Vinorelbine (DRUG), Anetumab ravtansine (BAY94-9343) (DRUG).
Who is sponsoring clinical trial NCT02610140?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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