Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
A Phase 2 Study of SB-715992 in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This phase II trial is studying how well SB-715992 works in treating patients with recurrent or metastatic head and neck cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
I. To determine the antitumor activity of SB-715992 in recurrent and/or metastatic squamous
cell carcinoma of the head and neck using objective response rates (partial and complete
responses).
SECONDARY OBJECTIVES:
I. To determine the duration of objective response, rate and duration of stable disease,
progression-free, median and overall survival rates of SB-715992 in recurrent and/or
metastatic squamous cell carcinoma of the head and neck.
II. To document the safety and tolerability of SB-715992 in recurrent and/or metastatic
squamous cell carcinoma of the head and neck.
III. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including
an assessment of significant covariates on SB-715992 PK and an assessment of the potential
relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy
endpoints.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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