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The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | TAS-109 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-109 | Drug | 14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period. Number of cycles: until unacceptable toxicity or disease progression requires discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Progression Free Survival | The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy. | From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Activity | Per RECIST Criteria and assessed by MRI: 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 rate was defined as percentage of patients of CR plus PR in ITT population. | From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Xiong, M.D., Ph.D. | The Center for Cancer and Blood Disorders | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Cancer Institute | East 34th Street, New York | New York | NY 10016 | United States | ||
| The University of Texas M.D. Anderson Cancer Center |
No screening period.
Patients with chemotherapy-refractory advanced colorectal cancer have been recruited at 3 study sites in US between January 2009 and November 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAS-109 | TAS-109 2.0 mg/m^2/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAS-109 | TAS-109 2.0 mg/m^2/day |
| 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 | Percentage of Progression Free Survival | The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy. | Analysis was Intent to treatment(ITT) population. | Posted | Number | 95% Confidence Interval | percentage of PFS patients | From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months. |
|
|
Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post 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-109 | TAS-109 2.0 mg/m^2/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Kopetz, MD | The University of Texas M.D. Anderson Cancer Center | 713-792-2828 |
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| Overall Survival | Overall survival is defined as the period from the date of first dose of TAS-109 to death date. | From the initial treatment until 12 months after enrollment of the last patient. |
| Holcombe Boulevard, Houston |
| Texas |
| TX 77030 |
| United States |
| The Center for Cancer and Blood Disorders | West Magnolia Avenue, Fort Worth | Texas | TX 76104 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Antitumor Activity | Per RECIST Criteria and assessed by MRI: 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 rate was defined as percentage of patients of CR plus PR in ITT population. | Intent to treatment(ITT) | Posted | Number | 95% Confidence Interval | percentage of CR plus PR patients | From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as the period from the date of first dose of TAS-109 to death date. | Analysis was Intent to Treat(ITT) population. | Posted | Median | 95% Confidence Interval | months | From the initial treatment until 12 months after enrollment of the last patient. |
|
|
|
| 9 |
| 26 |
| 26 |
| 26 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Catheter bacteremia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Disease Progression | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
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| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
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