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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Squamous Cell of Head and Neck

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Progression Free Survival (PFS)

Outcome Time Frame:

24 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

Sym004-02

NCT ID:

NCT01417936

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Carcinoma, Squamous Cell of Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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