Phase 2
N=26
Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
Carcinoma, Squamous Cell of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01417936 ↗Enrolled (actual)
26
Serious AEs
76.9%
Results posted
Feb 2016
Primary outcome: Primary: Progression Free Survival (PFS) Time — 82 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sym004 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Symphogen A/S
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Time |
82 | — |
| SECONDARY Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate) |
0; 0; 50.0; 23.1 | — |
| SECONDARY Duration of Overall Response |
— | — |
| SECONDARY Time to Progression (TTP) |
85 | — |
| SECONDARY Overall Survival Time |
156 | — |
| SECONDARY Number of Subjects With Detectable Biomarkers at Any Visit |
1; 0; 6; 0; 0; 0 | — |
| SECONDARY Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168]) |
17574.9; 25690.8 | — |
| SECONDARY Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf]) |
24620.8; 61655.7 | — |
| SECONDARY Maximum Serum Concentration (Cmax) |
248.4; 299.8 | — |
| SECONDARY Minimum Serum Concentration (Cmin) |
48.2; 93.6 | — |
| SECONDARY Clearance (CL) |
0.55; 0.22 | — |
| SECONDARY Terminal Half Life (T1/2) |
89.1; 140.7 | — |
| SECONDARY Time to Reach Maximum Serum Concentration (Tmax) |
6.0; 4.7 | — |
| SECONDARY Time to Reach Minimum Serum Concentration (Tmin) |
163.5; 58.4 | — |
| SECONDARY Volume of Distribution (Vz) |
67.0; 40.9 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation |
26; 20; 5; 6 | — |
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 included must have responded to previous anti-epidermal growth factor receptor (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 subjects with advanced SCCHN.
Symphogen was the sponsor for planning/conducting and reporting results for this trial.
Eligibility 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 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01417936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.