Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Symphogen A/S
Information provided by (Responsible Party):
Symphogen A/S
ClinicalTrials.gov Identifier:
NCT01417936
First received: July 15, 2011
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
The trial is designed as a multi-centre, open label phase II trial that investigates the efficacy and safety of Sym004 in patients with squamous cell cancer of the head and neck (SCCHN).
Patients included must have responded to previous anti-EGFR monoclonal antibody-based therapy and subsequently become resistant to that therapy.
It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to patients with advanced SCCHN.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Squamous Cell of Head and Neck |
Biological: Sym004 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Single Arm, Phase II Trial to Investigate the Safety and Efficacy of Sym004 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Have Failed Anti-EGFR Monoclonal Antibody-based Therapy |
Resource links provided by NLM:
Further study details as provided by Symphogen A/S:
Primary Outcome Measures:
- Rate of Progression Free Survival (PFS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse Events
- Objective Tumor Response
- Biomarkers
Tumor and skin biopsies are assessed for inhibition of EGFR and downstream intermediates.
Optional biomarker study will investigate associations between biological parameters and clinical features such as disease symptoms, drug response or potential adverse events.
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2011 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sym004
Weekly administration of Sym004
|
Biological: Sym004
Other Name: Sym004
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
- Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
Previous treatment with an anti-EGFR mAb in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
- Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
- Documented disease progression (verified by CT scan or MRI according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
- Accessible tumor for biopsy and patient acceptance of repeat tumor biopsies
Exclusion Criteria:
- More than 2 lines of prior chemotherapy in the palliative setting
- Expected survival <12 weeks
- Patients with known brain metastases
- Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
- Anti-EGFR mAbs within 14 days prior to Visit 2
- Major surgery within 4 weeks prior to Visit 2 and patients must have recovered from effects of major surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417936
Locations
| Belgium | |
| 3203; Antwerp University Hospital; Department of Medical Oncology | |
| Antwerp, Edegem, Belgium, 2650 | |
| 3201; Cliniques Universitaires St-Luc; Centre du Cancer | |
| Bruxelles, Belgium, 1200 | |
| 3202; Jules Bordet Institute; Clinique d'Oncologie Médicale | |
| Bruxelles, Belgium, 1000 | |
| France | |
| 3303; Centre Alexis Vautrin; Département d'Oncologie Médicale | |
| Nancy, Vandoeuvre Les Nancy, France, 54111 | |
| Germany | |
| 4905; Charité Campus Benjamin Franklin; Hematology, Oncology and Transfusion Medicine | |
| Berlin, Germany, 12200 | |
| 4901; Universitätsklinikum Essen | |
| Essen, Germany, 45122 | |
| 4904; Universitätsklinikum Freiburg | |
| Freiburg, Germany, 79106 | |
| 4906; University Medical Center Hamburg Eppendorf; Department of Otorhinolaryngology and Head and Neck Surgery | |
| Hamburg, Germany, 20246 | |
| 4907; University Hospital Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT) | |
| Heidelberg, Germany, 6912 | |
| 4902; University of Leipzig | |
| Leipzig, Germany, 04103 | |
Sponsors and Collaborators
Symphogen A/S
More Information
No publications provided
| Responsible Party: | Symphogen A/S |
| ClinicalTrials.gov Identifier: | NCT01417936 History of Changes |
| Other Study ID Numbers: | Sym004-02 |
| Study First Received: | July 15, 2011 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products France: Agence française de sécurité sanitaire des produits de santé (Afssaps) Germany: Paul-Erhlich-Institut, Federal Institute for Vaccines and Biomedicines |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013