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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
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterHouston, Texas  77030
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231