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NCT04515394 · ClinicalTrials.gov registry record · Phase 2
Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04515394: Clinical Trial Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT04515394 is a Phase 2 study that was terminated before completion, run by EMD Serono Research & Development Institute. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04515394, a Phase 2 study, was terminated before completion, sponsored by EMD Serono Research & Development Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.
Primary Outcome
DLTs are defined as any of the following toxicities and judged by Investigator and/ Sponsor to be not attributable to the disease/disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to \[\>=\] 3 febrile neutropenia with absolute neutrophil count \< 1000 per cube millimeter (per mm\^3) and a single temperature of \> 38.3 degree Celsius/a sustained temperature of \>= 38 degree Celsius for more than 1 hour; Grade 4/Grade 3 thrombocyto
Interventions
- BIOLOGICAL Cetuximab
- DRUG Tepotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 2 |
Why NCT04515394 stopped before completion
NCT04515394 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT04515394 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04515394 about?
NCT04515394 is a clinical study titled "Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)". The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (E...
What is the current status of trial NCT04515394?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2021-01-28. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT04515394?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Tepotinib (DRUG).
Who is sponsoring clinical trial NCT04515394?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04515394's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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