Phase II Study of TAS-106 to Treat Head and Neck Cancer - Full Text View

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00737360

Purpose

The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: TAS-106	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Progression free survival [ Time Frame: During study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Antitumor activity [ Time Frame: During the therapy ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 12 months after enrollment of the last patient ] [ Designated as safety issue: No ]
Safety [ Time Frame: During study treatment ] [ Designated as safety issue: Yes ]
Pharmacokinetics Assessment [ Time Frame: Course 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: TAS-106 6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737360

Contacts

Contact: Kazuhito Arakawa

+81-3-3293-2455

karakawa@taiho.co.jp

Locations

United States, Texas
M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Anne Tsao, MD

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

More Information

Responsible Party:	Clinical Research Department ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	TAS106-9905
Study First Received:	August 18, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00737360
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Head and Neck Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009