Phase II Study of TAS-106 to Treat Head and Neck Cancer
This study has been terminated.
Sponsor:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00737360
First received: August 18, 2008
Last updated: August 2, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of TAS-106 in Patients With Recurrent or Metastatic Head and Neck Cancer Refractory to Platinum Based Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Taiho Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Progression Free Survival(PFS) [ Time Frame: From the date of registration until the earliest date of documented disease progression, death, or censoring event. ] [ Designated as safety issue: No ]PFS was calculated as days from the date of registration until the earliest date of documented disease progression, death, or censoring event.
Secondary Outcome Measures:
- Antitumor Activity [ Time Frame: 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. ] [ Designated as safety issue: No ]Antitumor activity was evaluated by measuring the rate of objective response using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Per RECIST Criteria (V1.0) and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)= CR + PR.", or similar text that was as accurate and appropriate.
- Overall Survival [ Time Frame: 12 months after enrollment of the last patient ] [ Designated as safety issue: No ]Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011.
- Safety [ Time Frame: 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. ] [ Designated as safety issue: Yes ]Toxicities were evaluated at each course of therapy using the CTCAE ver. 3.0 or a non-CTC grading scale for toxicities that were not covered by the NCI CTC.
| Enrollment: | 27 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
Locations
| United States, Maryland | |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | |
| Orleans Street, Baltimore, Maryland, United States, 21231 | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Hong Kong | |
| The Chinese University of Hong Kong, Prince of Wales Hospital | |
| Shatin, HKSAR, Hong Kong | |
| Singapore | |
| National University Hospital | |
| Lower Kent Ridge Road, Singapore, 119074 | |
| Taiwan | |
| National Taiwan University Hospital Department of Oncology | |
| No. 1, Chang-De Street , Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
More Information
No publications provided
| Responsible Party: | Taiho Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00737360 History of Changes |
| Other Study ID Numbers: | TAS106-9905 |
| Study First Received: | August 18, 2008 |
| Results First Received: | April 20, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013