# A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck

> **NCT01177956** · PHASE3 · COMPLETED · sponsor: **Merck KGaA, Darmstadt, Germany** · enrollment: 73 (actual)

## Conditions studied

- Squamous Cell Carcinoma of the Head and Neck

## Interventions

- **BIOLOGICAL:** Cetuximab
- **DRUG:** Cisplatin
- **DRUG:** 5-Fluorouracil

## Key facts

- **NCT ID:** NCT01177956
- **Lead sponsor:** Merck KGaA, Darmstadt, Germany
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-12
- **Primary completion:** 2011-01
- **Final completion:** 2012-11
- **Target enrollment:** 73 (ACTUAL)
- **Last updated:** 2014-09-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01177956

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01177956, "A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT01177956. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
