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

NCT ID: NCT00737360

Last Updated: 2012-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

TAS-106

Intervention Type DRUG

6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Interventions

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TAS-106

6.5 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Orleans Street, Baltimore, Maryland, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hksar, , Hong Kong

Site Status

National University Hospital

Lower Kent Ridge Road, , Singapore

Site Status

National Taiwan University Hospital Department of Oncology

No. 1, Chang-De Street , Taipei, , Taiwan

Site Status

Countries

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United States Hong Kong Singapore Taiwan

Other Identifiers

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TAS106-9905

Identifier Type: -

Identifier Source: org_study_id