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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: Completed Phase 2 study, sponsored by Bayer.
NCT02610140 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 248 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
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 |
What the finished NCT02610140 record still lists
NCT02610140 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 0 conditions, and to 2 interventions - of which Vinorelbine is the first listed.
NCT02610140 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02610140's enrollment target sits among peer trials
248 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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