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

NCT00737360 | Terminated Phase 2 Results DMC

• 1 other identifier: TAS106-9905
• Study Type: interventional
• Target: 27
• Locations: 4 countries
• Sites: 5

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival(PFS)

  PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.

  From the date of registration until the earliest date of documented disease progression, death, or censoring event.

Secondary Outcomes (3)

• Antitumor Activity

  Obtain a contrast-enhanced CT scan of the chest, abdomen and pelvis (if clinically indicated) within 28 days prior to study entry and repeat at the end of every 2 courses thereafter.

• Overall Survival

  12 months after enrollment of the last patient

• Safety

  Monitor patients for untoward medical events from the time of signed informed consent form, including toxicities from previous treatment and any ongoing or newly reported AEs or SAEs during the 30 days after the last dose of study medication.

Study Arms (1)

1

EXPERIMENTAL

Drug: TAS-106

Interventions

TAS-106 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Radiological or clinical evidence of brain involvement or leptomeningeal disease
• ≥ grade 2 peripheral neuropathy
• History of another malignancy

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Orleans Street, Baltimore, Maryland, 21231, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hksar, Hong Kong

Location

National University Hospital

Lower Kent Ridge Road, 119074, Singapore

Location

National Taiwan University Hospital Department of Oncology

No. 1, Chang-De Street , Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

1-(3-C-ethynylribopentofuranosyl)cytosine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Dr. Anne Tsao, Principal Investigator
• Organization: The University of Texas M.D, Anderson Cancer Center

713-792-6363

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 19, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: September 5, 2012
• Results First Posted: September 5, 2012

Record last verified: 2012-08

Locations

US (2); SG (1); TW (1); HK (1)