Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy
Inclusion Criteria:
- Age 18 ≤ years old at study entry
- Histologically confirmed head and neck carcinoma
- Received prior platinum based regimen and developed disease progression or recurrence
- Measurable disease according to RECIST guidelines
Exclusion Criteria:
- Radiological or clinical evidence of brain involvement or leptomeningeal disease
- ≥ grade 2 peripheral neuropathy
- History of another malignancy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival(PFS)
Outcome Description:
PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
Outcome Time Frame:
From the date of registration until the earliest date of documented disease progression, death, or censoring event.
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
TAS106-9905
NCT ID:
NCT00737360
Start Date:
August 2008
Completion Date:
February 2012
Related Keywords:
- Head and Neck Cancer
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
