Trial intelligence / Profile preview

Cediranib in Recurrent or Metastatic Head and Neck Cancer

NCT00458978Phase 2

Key facts

Status: Completed
Start: Feb 2007
Primary completion: May 2013
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: cediranib
Conditions: head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 2, open-label, single-arm trial of cediranib in head and neck squamous cell carcinoma (HNSCC), sponsored by National Cancer Institute. Primary endpoint: Objective Clinical Response at Day 29. Started Feb 2007; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment (enzyme inhibitor)
Patients receive oral cediranib maleate once daily.

Who it enrols

Patients with histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck who have failed standard curative therapy and have measurable disease.

Endpoints

Primary

Objective Clinical ResponseDay 29

Secondary

Adverse EventsUp to 28 days after last dose
Distant MetastasisEvery 2 courses until progression
Overall SurvivalUp to 28 days after last dose
Progression-Free SurvivalUp to 28 days after last dose

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