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NCT02568046 · ClinicalTrials.gov registry record · Phase 1

Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

A Phase 1 study, sponsored by Symphogen A/S.

Terminated
Registry status
Phase 1
Development phase
10
Enrollment target

NCT02568046: Clinical Trial Phase 1 study, sponsored by Symphogen A/S.

NCT02568046 is a Phase 1 study that was terminated before completion, run by Symphogen A/S. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02568046, a Phase 1 study, was terminated before completion, sponsored by Symphogen A/S.

TERMINATED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).

Primary Outcome

AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (e.g., treatment-emergent AE \[TEAE\]) were summarized according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred after the first treatment administration.

Interventions

  • DRUG FOLFIRI
  • DRUG Sym004

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-03-15
Est. Completion 2018-05-05
Phase Phase 1
Symphogen A/S

12 total trials

Why NCT02568046 stopped before completion

NCT02568046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

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

NCT02568046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02568046 about?

NCT02568046 is a clinical study titled "Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients". This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).

What is the current status of trial NCT02568046?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-03-15. Estimated completion is 2018-05-05.

What interventions are being tested in trial NCT02568046?

The interventions under investigation include: FOLFIRI (DRUG), Sym004 (DRUG).

Who is sponsoring clinical trial NCT02568046?

This trial is sponsored by Symphogen A/S, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02568046's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 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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Source: ClinicalTrials.gov NCT02568046, the US trial registry maintained by the National Library of Medicine. NCT02568046 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.