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Trial record 76 of 477 for:    colon cancer | ( Map: Texas, United States )

Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00824161
Recruitment Status : Terminated
First Posted : January 16, 2009
Results First Posted : August 17, 2011
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Colorectal Cancer
Intervention Drug: TAS-109
Enrollment 28
Recruitment Details Patients with chemotherapy-refractory advanced colorectal cancer have been recruited at 3 study sites in US between January 2009 and November 2009.
Pre-assignment Details No screening period.
Arm/Group Title TAS-109
Hide Arm/Group Description TAS-109 2.0 mg/m^2/day
Period Title: Overall Study
Started 28
Completed 26
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Screen Failure             1
Arm/Group Title TAS-109
Hide Arm/Group Description TAS-109 2.0 mg/m^2/day
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  71.4%
>=65 years
8
  28.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
55.8  (10.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
17
  60.7%
Male
11
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Percentage of Progression Free Survival
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was Intent to treatment(ITT) population.
Arm/Group Title TAS-109
Hide Arm/Group Description:
TAS-109 2.0 mg/m^2/day Independent Assessment
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of PFS patients
75.0
(55.1 to 89.3)
2.Secondary Outcome
Title Antitumor Activity
Hide Description 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.
Time Frame From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treatment(ITT)
Arm/Group Title TAS-109
Hide Arm/Group Description:
TAS-109 2.0 mg/m^2/day
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of CR plus PR patients
0
(0.0 to 12.3)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
Time Frame From the initial treatment until 12 months after enrollment of the last patient.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was Intent to Treat(ITT) population.
Arm/Group Title TAS-109
Hide Arm/Group Description:
TAS-109 2.0 mg/m^2/day
Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: months
5.5 [1] 
(3.7 to NA)
[1]
As this study was terminated on the way, the upper bound of 95% CI was not calculated.
Time Frame Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAS-109
Hide Arm/Group Description TAS-109 2.0 mg/m^2/day
All-Cause Mortality
TAS-109
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAS-109
Affected / at Risk (%)
Total   9/26 (34.62%) 
Blood and lymphatic system disorders   
Anaemia  1  1/26 (3.85%) 
Neutropenia  1  1/26 (3.85%) 
Gastrointestinal disorders   
Gastrointestinal obstruction  1  1/26 (3.85%) 
Small intestinal obstruction  1  2/26 (7.69%) 
General disorders   
Disease progression  1  2/26 (7.69%) 
Pyrexia  1  1/26 (3.85%) 
Infections and infestations   
Catheter bacteremia  1  1/26 (3.85%) 
Pneumonia  1  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAS-109
Affected / at Risk (%)
Total   26/26 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  7/26 (26.92%) 
Leukopenia  1  4/26 (15.38%) 
Lymphopenia  1  3/26 (11.54%) 
Neutropenia  1  11/26 (42.31%) 
Thrombocytopenia  1  3/26 (11.54%) 
Cardiac disorders   
Tachycardia  1  2/26 (7.69%) 
Gastrointestinal disorders   
Abdominal Pain  1  4/26 (15.38%) 
Ascites  1  2/26 (7.69%) 
Constipation  1  6/26 (23.08%) 
Diarrhoea  1  8/26 (30.77%) 
Nausea  1  10/26 (38.46%) 
Proctalgia  1  2/26 (7.69%) 
Small Intestinal Obstruction  1  2/26 (7.69%) 
Stomatitis  1  2/26 (7.69%) 
Vomiting  1  7/26 (26.92%) 
General disorders   
Chills  1  3/26 (11.54%) 
Disease Progression  1  2/26 (7.69%) 
Fatigue  1  14/26 (53.85%) 
Oedema Peripheral  1  2/26 (7.69%) 
Pyrexia  1  4/26 (15.38%) 
Hepatobiliary disorders   
Hepatomegaly  1  2/26 (7.69%) 
Hyperbilirubinaemia  1  2/26 (7.69%) 
Jaundice  1  2/26 (7.69%) 
Infections and infestations   
Pneumonia  1  2/26 (7.69%) 
Urinary Tract Infection  1  3/26 (11.54%) 
Investigations   
Blood Alkaline Phosphatase Increased  1  3/26 (11.54%) 
Haemoglobin Decreased  1  2/26 (7.69%) 
Metabolism and nutrition disorders   
Anorexia  1  8/26 (30.77%) 
Dehydration  1  2/26 (7.69%) 
Hypoalbuminaemia  1  2/26 (7.69%) 
Hypokalaemia  1  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  4/26 (15.38%) 
Nervous system disorders   
Headache  1  2/26 (7.69%) 
Renal and urinary disorders   
Dysuria  1  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/26 (11.54%) 
Pleural Effusion  1  2/26 (7.69%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  6/26 (23.08%) 
Vascular disorders   
Deep Vein Thrombosis  1  2/26 (7.69%) 
Hypotension  1  2/26 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Kopetz, MD
Organization: The University of Texas M.D. Anderson Cancer Center
Phone: 713-792-2828
Layout table for additonal information
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00824161     History of Changes
Other Study ID Numbers: TAS109-0403
First Submitted: January 14, 2009
First Posted: January 16, 2009
Results First Submitted: June 21, 2011
Results First Posted: August 17, 2011
Last Update Posted: April 23, 2012