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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Activity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Orleans Street, Baltimore | Maryland | 21231 | United States | ||
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The patient enrollment was started from 24/Sep/2008 and terminated as of 30/Sep/2010. In the nasopharyngeal carcinoma (NPC) subgroup and squamous cell carcinoma (SCCHN) subgroup of stage 1, 13 and 14 patients were enrolled, respectively. For both subgroups subsequent enrollment was not reopened for the second stage, thus 27 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAS-106 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAS-106 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One patient enrolled was discontinued without any post-baseline tumor assessment, therefore, 26 patients were included in the efficacy analyzes. | Posted | Median | 95% Confidence Interval | day | From the date of registration until the earliest date of documented disease progression, death, or censoring event. |
|
|
Adverse events were summarized for all courses of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAS-106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Tsao, Principal Investigator | The University of Texas M.D, Anderson Cancer Center | 713-792-6363 |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C103084 | 1-(3-C-ethynylribopentofuranosyl)cytosine |
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| 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 | Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011. | 12 months after enrollment of the last patient |
| Safety | 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. | 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. |
| University of Texas MD Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| The Chinese University of Hong Kong, Prince of Wales Hospital | Shatin, Hksar | Hong Kong |
| National University Hospital | Lower Kent Ridge Road | 119074 | Singapore |
| National Taiwan University Hospital Department of Oncology | No. 1, Chang-De Street , Taipei | 100 | Taiwan |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Antitumor Activity | 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. | Antitumor activity was the rate of best overall objective responses(complete response + partial response). | Posted | Number | participants | 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. |
|
|
|
| Secondary | Overall Survival | Patient survival for both subgroups was followed up every 2 months until 28 Feb 2011. | Posted | Median | 95% Confidence Interval | day | 12 months after enrollment of the last patient |
|
|
|
| Secondary | Safety | 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. | All patients who received at least 1 dose of TAS-106 were the primary population for the safety evaluation. | Posted | Number | number of participants | 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. |
|
|
|
| 15 |
| 27 |
| 27 |
| 27 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Face oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Lymph node abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Hemoglobin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Face oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Infusion site discolouration | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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