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NCT02083653 · ClinicalTrials.gov registry record · Phase 2

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

A Phase 2 study, sponsored by Symphogen A/S.

Completed
Registry status
Phase 2
Development phase
254
Enrollment target

NCT02083653 is a Phase 2 study that has completed, run by Symphogen A/S. The registered enrollment target is 254 participants.

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The verdict

NCT02083653, a Phase 2 study, has completed, sponsored by Symphogen A/S.

COMPLETED
Registry status
Phase 2
Development phase
254 participants
Enrollment target

Study Summary

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Interventions

  • DRUG Capecitabine
  • DRUG Fluorouracil (5-FU)
  • OTHER Best Supportive Care (BSC)
  • DRUG Sym004 (12 mg/kg)
  • DRUG Sym004 (9/6 mg/kg)

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2014-03-06
Est. Completion 2017-04-26
Phase Phase 2

Sponsor

Symphogen A/S

12 total trials

What the Registry Record Tells You About NCT02083653

The ClinicalTrials.gov registry entry for NCT02083653 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Symphogen A/S, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.

NCT02083653 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02083653 about?

NCT02083653 is a clinical study titled "Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer". This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibo...

What is the current status of trial NCT02083653?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2014-03-06. Estimated completion is 2017-04-26.

What interventions are being tested in trial NCT02083653?

The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (5-FU) (DRUG), Best Supportive Care (BSC) (OTHER), Sym004 (12 mg/kg) (DRUG), Sym004 (9/6 mg/kg) (DRUG).

Who is sponsoring clinical trial NCT02083653?

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

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

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.