Open-label, randomized, controlled Phase I/II study of cilengitide to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-FU, and cetuximab in subjects with recurrent/metastatic squamous cell cancer of the head and neck. - ADVANTAGE

Phase 1

• Conditions: Recurrent/metastatic squamous cell cancer of the head and neck.; MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2008-000615-15-FR
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-13
• Study Completion: 2013-06-20
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of SCCHN.
2. At least one measurable lesion either by CT scan or MRI.
3. KPS of =70/ECOG PS of 0-1 at study entry
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. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanceddisease which was completed more than 6 months prior to study entry.
2. Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry.
3. Nasopharyngeal carcinoma.
4. Documented or symptomatic brain or leptomeningeal metastasis.
5. Previous treatment with epidermal growth factor receptor (EGFR) targeting therapy or signal transduction inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified