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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: Completed Phase 2 study, sponsored by Symphogen A/S.
NCT02083653 is a Phase 2 study that has completed, run by Symphogen A/S. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. If a subject had not died, survival time was censored at the last date the subject was known to be alive.
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
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2014-03-06 |
| Est. Completion | 2017-04-26 |
| Phase | Phase 2 |
What the finished NCT02083653 record still lists
NCT02083653 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT02083653 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02083653's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 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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