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NCT02134197 · ClinicalTrials.gov registry record · Phase 1
Dose-escalation Study of Lupartumab Amadotin (BAY1129980)
A Phase 1 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT02134197: Clinical Trial Phase 1 study, sponsored by Bayer.
NCT02134197 is a Phase 1 study that was terminated before completion, run by Bayer. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02134197, a Phase 1 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate: * The side effects of BAY1129980 when given every 21 days different dose levels. * Determine the dose level of BAY1129980 that should be tested in future clinical research studies. * Measure how much BAY1129980 is in the blood at specific times after administration. * If treatment with BAY1129980 shows any effect on reducing the tumor growth. * If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not. * If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).
Primary Outcome
MTD is defined as the maximum dose at which the incidence of DLTs (dose limiting toxicities) during Cycle 1 is below 20%, or the maximum dose administered, whichever is achieved first during dose escalation.
Interventions
- DRUG Lupartumab Amadotin (BAY1129980)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-05-22 |
| Est. Completion | 2018-08-30 |
| Phase | Phase 1 |
Why NCT02134197 stopped before completion
NCT02134197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 1 intervention - of which Lupartumab Amadotin (BAY1129980) is the first listed.
NCT02134197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02134197 about?
NCT02134197 is a clinical study titled "Dose-escalation Study of Lupartumab Amadotin (BAY1129980)". The purpose of this study is to evaluate: * The side effects of BAY1129980 when given every 21 days different dose levels. * Determine the dose level of BAY1129980 that should be tested in future clinical research studies. * Measure how much BAY1129980 is in the blood at specific times after admini...
What is the current status of trial NCT02134197?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2014-05-22. Estimated completion is 2018-08-30.
What interventions are being tested in trial NCT02134197?
The interventions under investigation include: Lupartumab Amadotin (BAY1129980) (DRUG).
Who is sponsoring clinical trial NCT02134197?
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 NCT02134197's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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