Status:
COMPLETED
Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
Lead Sponsor:
Symphogen A/S
Conditions:
Carcinoma, Squamous Cell of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects inclu...
Eligibility Criteria
Inclusion
- 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 monoclonal antibody (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 computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
- Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
- Other protocol-defined inclusion criteria could apply
Exclusion
- More than 2 lines of prior chemotherapy in the palliative setting
- Expected survival \<12 weeks
- Subjects 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 subjects must have recovered from effects of major surgery
- Other protocol-defined exclusion criteria could apply
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01417936
Start Date
July 1 2011
End Date
October 1 2012
Last Update
October 15 2018
Active Locations (10)
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1
3203; Antwerp University Hospital; Department of Medical Oncology
Antwerp, Edegem, Belgium, 2650
2
3202; Jules Bordet Institute; Clinique d'Oncologie Médicale
Brussels, Belgium, 1000
3
3201; Cliniques Universitaires St-Luc; Centre du Cancer
Brussels, Belgium, 1200
4
3303; Centre Alexis Vautrin; Département d'Oncologie Médicale
Nancy, Vandoeuvre Les Nancy, France, 54111