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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 is a Phase 1 study that was terminated before completion, run by EMD Serono. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02083679
The ClinicalTrials.gov registry entry for NCT02083679 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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