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NCT01040832 · ClinicalTrials.gov registry record · Phase 2
EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
NCT01040832 is a Phase 2 study that has completed, run by EMD Serono. The registered enrollment target is 107 participants.
The verdict
NCT01040832, a Phase 2 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer. EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9). EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two studies have been conducted in healthy volunteers. In the other five studies, subjects with advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of the head and neck (SCCHN). In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab alone. The study will be conducted as a multicenter study in several European Union (EU) member states and the Unites States. EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in subjects by examining its effects on accepted clinical endpoints. Progression-free survival (PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a cytotoxic therapy. Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as investigational medicinal product (IMP) in this study. Commercially available Cetuximab will be provided in the United States.
Interventions
- DRUG Cetuximab
- DRUG EMD 1201081
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2009-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01040832
The ClinicalTrials.gov registry entry for NCT01040832 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 107 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 2 interventions - of which Cetuximab is the first listed.
NCT01040832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01040832 about?
NCT01040832 is a clinical study titled "EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is more efficient than cetuximab alone to control the cancer. EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate oligodeoxynucleotide and acts as an agonist of Toll-like recepto...
What is the current status of trial NCT01040832?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2009-12.
What interventions are being tested in trial NCT01040832?
The interventions under investigation include: Cetuximab (DRUG), EMD 1201081 (DRUG).
Who is sponsoring clinical trial NCT01040832?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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