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NCT03102320 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 173
- Enrollment target
NCT03102320 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 173 participants.
The verdict
NCT03102320, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 173 participants
- Enrollment target
Study Summary
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. 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 will also be collected for mesothelin expression testing and biomarker analyses.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Anetumab ravtansine (BAY94-9343)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2017-05-26 |
| Est. Completion | 2021-07-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03102320
The ClinicalTrials.gov registry entry for NCT03102320 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 173 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 3 interventions - of which Cisplatin is the first listed.
NCT03102320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03102320 about?
NCT03102320 is a clinical study titled "Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors". The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerab...
What is the current status of trial NCT03102320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 173 participants. The study started on 2017-05-26. Estimated completion is 2021-07-26.
What interventions are being tested in trial NCT03102320?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Anetumab ravtansine (BAY94-9343) (DRUG).
Who is sponsoring clinical trial NCT03102320?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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