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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 is a Phase 1 study that has completed, run by Menarini Group. The registered enrollment target is 29 participants.

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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.

Interventions

  • DRUG Cetuximab
  • DRUG MEN1611

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2020-07-20
Est. Completion 2024-02-27
Phase Phase 1

Sponsor

Menarini Group

9 total trials

What the Registry Record Tells You About NCT04495621

The ClinicalTrials.gov registry entry for NCT04495621 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Menarini Group, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Cetuximab is the first listed.

NCT04495621 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.