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NCT04495621 · ClinicalTrials.gov registry record · Phase 1
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
A Phase 1 study, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT04495621: Completed Phase 1 study, sponsored by Menarini Group.
NCT04495621 is a Phase 1 study that has completed, run by Menarini Group. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04495621, a Phase 1 study, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.
Primary Outcome
RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant during the dose confirmation phase (Phase 1b) experienced a dose-limiting toxicity (DLT) during the DLT assessment window (28 days), or the maximum dose judged to be tolerable by the data safety committee.
Interventions
- DRUG Cetuximab
- DRUG MEN1611
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2024-02-27 |
| Phase | Phase 1 |
What the finished NCT04495621 record still lists
NCT04495621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.
NCT04495621 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04495621 about?
NCT04495621 is a clinical study titled "MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)". Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic...
What is the current status of trial NCT04495621?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2020-07-20. Estimated completion is 2024-02-27.
What interventions are being tested in trial NCT04495621?
The interventions under investigation include: Cetuximab (DRUG), MEN1611 (DRUG).
Who is sponsoring clinical trial NCT04495621?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04495621's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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