Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000615-15-BE

Enrollment

177

Registered

2008-05-06

Start date

2008-07-14

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/metastatic squamous cell cancer of the head and neck. MedDRA version: 15.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 100000004864

Interventions

Product Name: Cilengitide Product Code: EMD 121974 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cilengitide CAS Number: 188968-51-6 Current Sponsor code: EMD 121974 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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. 6. Left ventricular ejection fraction < 40%

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase I part: safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU Phase II part: Progression Free Survival ;Secondary Objective: Phase I part: - overall survival time - best overall response - disease control - duration of response - time to treatment failure Phase II part: - safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU in the overall study population - overall survival time - best overall response - disease control - duration of response - time to treatment failure. - pharmacokinetic (PK) profiles of cilengitide and cetuximab when cilengitide is given in combination with cetuximab and cisplatin.;Primary end point(s): - Progression free survival time;Timepoint(s) of evaluation of this end point: -12 months after randomization of last subject	—

Measure

Time frame

Main Objective: Phase I part: safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU Phase II part: Progression Free Survival ;Secondary Objective: Phase I part: - overall survival time - best overall response - disease control - duration of response - time to treatment failure Phase II part: - safety and tolerability of the combination of cilengitide with cetuximab, cisplatin, and 5-FU in the overall study population - overall survival time - best overall response - disease control - duration of response - time to treatment failure. - pharmacokinetic (PK) profiles of cilengitide and cetuximab when cilengitide is given in combination with cetuximab and cisplatin.;Primary end point(s): - Progression free survival time;Timepoint(s) of evaluation of this end point: -12 months after randomization of last subject

—

Secondary

Measure	Time frame
Secondary end point(s): - Overall survival time - Best overall response - Disease control rate - Duration of response - Time to treatment failure;Timepoint(s) of evaluation of this end point: -12 months after randomization of last subject	—

Countries

Austria, Belgium, France, Germany, Hungary, Italy, Switzerland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026