A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) - EMD 1201081 in Cetuximab-Naïve Subjects with R/M SCCH

Phase 1

Conditions: Recurrent/metastatic squamous cell cancer of the head and neck
MedDRA version: 12.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

Registration Number: EUCTR2009-014440-10-FR

Lead Sponsor: Merck KGaA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

1. Signed and dated written informed consent prior to any trial-specific procedure.
2. Male or female, age = 18 years.
3. Histologically confirmed squamous cell carcinoma of the head and neck that is recurrent and/or metastatic; documented in the medical record.
4. History of progressing disease on a first-line cytotoxic chemotherapy regimen such as 5-FU + cisplatin, taxanes, etc. for their R/M SCCHN. (A history of chemotherapy/ radiation therapy for localized disease does not count as a first-line regimen.)
5. The subject is suited for systemic therapy in the opinion of the Investigator.
6. At least one radiographically documented lesion assessable according to RECIST 1.0. Lesions in previously irradiated areas should be measurable (i.e. the lesion must be adequately measurable in at least one dimension; longest diameter to be recorded as = 2 cm by conventional techniques or = 1 cm by spiral CT scan).
7. ECOG performance status of 0 or 1.
8. If female, either post-menopausal, surgically sterile, or having a negative urine or serum pregnancy test (ß-HCG) at screening and practicing medically accepted contraception. If male, practicing contraception if risk of conception exists. For relevant subjects, the duration of contraception should be 1 week prior to the start of therapy for females through receipt of trial therapy and at the start of trial therapy through receipt of trial therapy for males.
9. Recovered from previous toxicities of prior cytotoxic regimen to CTCAE Grade 1 (with the exception of alopecia).
10. Hemoglobin = 9 g/dL (without transfusion support, no transfusion within 7 days of screening).
11. Neutrophils = 1.5 x 109/L.
12. Platelets = 100 x 109/L.
13. PT/PTT = 1.5 times the upper limit of normal for the site, unless there is therapeutic anti-coagulation.
14. Serum creatinine = 1.5 times the upper limit of normal for the site.
15. ALT and AST = 3 times the upper limit of normal for the site.
16. Be willing and able to comply with the protocol procedures for the duration of the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of prior exposure to cetuximab or panitumumab or any other approved or investigational anti-EGFR agents.
2. Undifferentiated nasopharyngeal carcinoma.
3. Chemotherapy, radiotherapy or any investigational agents within 4 weeks of first dose of trial medication.
4. Major surgical or planned procedure within 30 days of first dose of trial medication (isolated biopsies are not counted as major surgical procedures).
5. Other active malignancy besides non-metastatic basal cell or squamous cell carcinoma of the skin.
6. Pregnancy or breast feeding.
7. Legal incapacity or limited legal capacity.
8. Significant medical or psychiatric disease which makes the trial inappropriate for the subject in the Investigator’s opinion.
9. Any brain metastasis and/or leptomeningeal disease (known or suspected).
10. Significant pre-existing immune deficiency such as infection by HIV (documented or known).
11. Clinically significant ongoing infection.
12. Known hypersensitivity to the trial treatments.
13. Participation in another clinical trial within the past 30 days.
14. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
15. Other significant disease that in the Investigator’s opinion would exclude the subject from the trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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