Status:
COMPLETED
Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Squamous Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengi...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of SCCHN
- At least one measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI)
- Karnofsky performance status (KPS) of greater than or equal to 70 or eastern cooperative oncology group performance status (ECOG PS) of 0-1 at trial entry
Exclusion
- Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease, which was completed more than 6 months prior to trial entry
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- Nasopharyngeal Carcinoma
- Documented or symptomatic brain or leptomeningeal metastasis
- Previous treatment with epidermal growth factor receptor (EGFR) targeting therapy or signal transduction inhibitors
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00705016
Start Date
October 1 2008
End Date
June 1 2013
Last Update
April 30 2014
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Salzburg, Austria
2
Research Site
Vienna, Austria
3
Research Site
Antwerp, Belgium
4
Research Site
Brussels, Belgium