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NCT02083679 · ClinicalTrials.gov registry record · Phase 1
Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
A Phase 1 study, sponsored by EMD Serono.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02083679: Clinical Trial Phase 1 study, sponsored by EMD Serono.
NCT02083679 is a Phase 1 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02083679, a Phase 1 study, was terminated before completion, sponsored by EMD Serono.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC). The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015.
Primary Outcome
DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not \>5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not \>5 days; fatigue/headache lasting \< 7 days; nausea/
Interventions
- DRUG Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine
- DRUG Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed
- DRUG Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel
- DRUG Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
Why NCT02083679 stopped before completion
NCT02083679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine is the first listed.
NCT02083679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02083679 about?
NCT02083679 is a clinical study titled "Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer". This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung Cancer (NSCLC). The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontin...
What is the current status of trial NCT02083679?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-07. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02083679?
The interventions under investigation include: Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine (DRUG), Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed (DRUG), Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel (DRUG), Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02083679?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02083679's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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