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Trial record 34 of 59 for:    TAS-102

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies (RECOURSE)

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: NCT01607957
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: TAS-102
Drug: Placebo
Enrollment 800
Recruitment Details This was a multicenter study conducted in 101 study centers in 13 countries including the United States, Japan, Spain, Italy, Germany, Belgium, France, Australia, United Kingdom, Austria, Ireland, Sweden, and Czech Republic.
Pre-assignment Details Total 1002 participants provided consent, out of which 800 participants were randomized in 2:1 ratio in TAS-102 and placebo treatment groups respectively.
Arm/Group Title TAS-102 Placebo
Hide Arm/Group Description Participants received TAS-102 orally with a starting dose of 35 milligram per meter square per dose (mg/m^2/dose) twice daily (BID) based on body surface area (BSA) along with best supportive care (BSC). The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met. Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7. The treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
Period Title: Overall Study
Started 534 266
Treated 533 265
Completed 162 51
Not Completed 372 215
Reason Not Completed
Not treated             1             1
Death             367             211
Lost to Follow-up             3             3
Participant refusal             1             0
Arm/Group Title TAS-102 Placebo Total
Hide Arm/Group Description Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met. Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria. Total of all reporting groups
Overall Number of Baseline Participants 534 266 800
Hide Baseline Analysis Population Description
Analysis was performed in Intent-to-Treat (ITT) population which included all randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 266 participants 800 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
300
  56.2%
148
  55.6%
448
  56.0%
>=65 years
234
  43.8%
118
  44.4%
352
  44.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 534 participants 266 participants 800 participants
61.5  (10.21) 61.5  (10.51) 61.5  (10.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 534 participants 266 participants 800 participants
Female
208
  39.0%
101
  38.0%
309
  38.6%
Male
326
  61.0%
165
  62.0%
491
  61.4%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.
Time Frame Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in ITT population. For participants who were alive as of the overall survival cutoff date, their survival was censored on the cutoff date post consent.
Arm/Group Title TAS-102 Placebo
Hide Arm/Group Description:
Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
Overall Number of Participants Analyzed 534 266
Median (95% Confidence Interval)
Unit of Measure: months
7.1
(6.5 to 7.8)
5.3
(4.6 to 6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.58 to 0.81
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival
Hide Description Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.
Time Frame Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in ITT population.
Arm/Group Title TAS-102 Placebo
Hide Arm/Group Description:
Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
Overall Number of Participants Analyzed 534 266
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.9 to 2.1)
1.7
(1.7 to 1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.41 to 0.57
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.
Time Frame From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.
Arm/Group Title TAS-102 Placebo
Hide Arm/Group Description:
Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.
Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
Overall Number of Participants Analyzed 533 265
Measure Type: Number
Unit of Measure: percentage of participants
Any adverse event (AE) 98.3 93.2
Any treatment-related AE 85.7 54.7
Any ≥Grade 3 AE 69.4 51.7
Any treatment-related ≥Grade 3 AE 49.0 9.8
Any serious AE (SAE) 29.6 33.6
Any AE resulting in discontinuation 10.3 13.6
Any AE with outcome of death 3.2 11.3
Time Frame From the time of signing the informed consent form until the period of participant follow up (30 days following the administration of last dose of study medication or until initiation of new anti-tumor therapy, whichever was earlier, up to 85 weeks approximately (duration of study)).
Adverse Event Reporting Description Safety analysis was performed on AT population including all participants who took part of any dose of the study medication.
 
Arm/Group Title TAS-102 Placebo
Hide Arm/Group Description Participants received TAS-102 orally with a starting dose of 35 mg/m^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met. Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.
All-Cause Mortality
TAS-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   17/533 (3.19%)      30/265 (11.32%)    
Show Serious Adverse Events Hide Serious Adverse Events
TAS-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   158/533 (29.64%)      89/265 (33.58%)    
Blood and lymphatic system disorders     
Anaemia  1  10/533 (1.88%)  10 0/265 (0.00%)  0
Disseminated intravascular coagulation  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Febrile neutropenia  1  14/533 (2.63%)  14 0/265 (0.00%)  0
Leukopenia  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Neutropenia  1  4/533 (0.75%)  4 0/265 (0.00%)  0
Pancytopenia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Thrombocytopenia  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Cardiac tamponade  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Cardio-Respiratory arrest  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Myocardial ischaemia  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Pericardial effusion  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Sinus bradycardia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Eye disorders     
Cataract  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Abdominal pain  1  8/533 (1.50%)  8 5/265 (1.89%)  5
Ascites  1  3/533 (0.56%)  3 3/265 (1.13%)  3
Colitis  1  1/533 (0.19%)  2 0/265 (0.00%)  0
Constipation  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Diarrhoea  1  4/533 (0.75%)  4 0/265 (0.00%)  0
Gastrointestinal haemorrhage  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Haematemesis  1  0/533 (0.00%)  0 2/265 (0.75%)  2
Haemorrhoids  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Ileus  1  3/533 (0.56%)  3 5/265 (1.89%)  5
Intestinal obstruction  1  2/533 (0.38%)  2 1/265 (0.38%)  1
Intestinal perforation  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Large intestinal obstruction  1  3/533 (0.56%)  3 1/265 (0.38%)  1
Lower gastrointestinal haemorrhage  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Mechanical ileus  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Nausea  1  3/533 (0.56%)  3 0/265 (0.00%)  0
Pancreatitis acute  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Rectal haemorrhage  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Rectal perforation  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Rectal stenosis  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Sigmoiditis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Small intestinal obstruction  1  5/533 (0.94%)  6 1/265 (0.38%)  3
Subileus  1  2/533 (0.38%)  3 0/265 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Vomiting  1  7/533 (1.31%)  7 0/265 (0.00%)  0
General disorders     
Asthenia  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Fatigue  1  3/533 (0.56%)  3 2/265 (0.75%)  2
General physical health deterioration  1  15/533 (2.81%)  15 11/265 (4.15%)  11
Hyperpyrexia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Malaise  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Multi-Organ failure  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Obstruction  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Oedema peripheral  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Pain  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Pyrexia  1  5/533 (0.94%)  5 1/265 (0.38%)  1
Hepatobiliary disorders     
Bile duct obstruction  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Bile duct stenosis  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Cholangitis  1  3/533 (0.56%)  3 1/265 (0.38%)  1
Cholangitis acute  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Cholecystitis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Cholestasis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Hepatic failure  1  3/533 (0.56%)  3 6/265 (2.26%)  6
Hepatic pain  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Hyperbilirubinaemia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Jaundice  1  3/533 (0.56%)  3 2/265 (0.75%)  2
Jaundice cholestatic  1  4/533 (0.75%)  4 2/265 (0.75%)  2
Infections and infestations     
Bacteraemia  1  2/533 (0.38%)  2 1/265 (0.38%)  1
Biliary tract infection  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Bronchopneumonia  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Catheter site infection  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Cellulitis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Device related infection  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Enteritis infectious  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Escherichia urinary tract infection  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Herpes zoster  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Infection  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Kidney infection  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Liver abscess  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Lower respiratory tract infection  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Lung infection  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Peritonitis bacterial  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Pneumonia  1  3/533 (0.56%)  3 2/265 (0.75%)  2
Pneumonia klebsiella  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Pneumonia staphylococcal  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Pyelonephritis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Sepsis  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Septic shock  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Streptococcal bacteraemia  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Urinary tract infection  1  2/533 (0.38%)  2 3/265 (1.13%)  4
Injury, poisoning and procedural complications     
Extradural haematoma  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Fall  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Femoral neck fracture  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Fracture  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Injury  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Medication error  1  5/533 (0.94%)  5 0/265 (0.00%)  0
Overdose  1  4/533 (0.75%)  4 0/265 (0.00%)  0
Tracheal obstruction  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Aspartate aminotransferase increased  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Blood bilirubin increased  1  1/533 (0.19%)  1 2/265 (0.75%)  2
Blood creatinine increased  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Blood lactate dehydrogenase increased  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Weight decreased  1  1/533 (0.19%)  1 0/265 (0.00%)  0
White blood cell count decreased  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Decreased appetite  1  3/533 (0.56%)  4 5/265 (1.89%)  5
Dehydration  1  3/533 (0.56%)  3 0/265 (0.00%)  0
Failure to thrive  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Hyperglycaemia  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Hypokalaemia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Hyponatraemia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Back pain  1  3/533 (0.56%)  3 2/265 (0.75%)  3
Flank pain  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Groin pain  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Intervertebral disc protrusion  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Musculoskeletal pain  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Pain in extremity  1  0/533 (0.00%)  0 2/265 (0.75%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Lymphangiosis carcinomatosa  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Malignant ascites  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Metastases to peritoneum  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Metastasis  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Tumour associated fever  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Tumour pain  1  3/533 (0.56%)  3 3/265 (1.13%)  3
Nervous system disorders     
Brain compression  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Brain oedema  1  2/533 (0.38%)  2 1/265 (0.38%)  1
Cognitive disorder  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Convulsion  1  2/533 (0.38%)  2 1/265 (0.38%)  1
Epiduritis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Haemorrhage intracranial  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Hemiparesis  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Hepatic encephalopathy  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Loss of consciousness  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Monoparesis  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Nerve root compression  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Neurological decompensation  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Psychomotor skills impaired  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Spinal cord compression  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Renal and urinary disorders     
Haematuria  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Hydronephrosis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Nephrolithiasis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Postrenal failure  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Renal failure  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Renal failure acute  1  5/533 (0.94%)  5 0/265 (0.00%)  0
Renal impairment  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Urinary retention  1  2/533 (0.38%)  2 0/265 (0.00%)  0
Urinary tract obstruction  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Dyspnoea  1  3/533 (0.56%)  3 6/265 (2.26%)  6
Haemoptysis  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Pleural effusion  1  3/533 (0.56%)  3 3/265 (1.13%)  3
Pneumonia aspiration  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Pulmonary congestion  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Pulmonary embolism  1  6/533 (1.13%)  6 0/265 (0.00%)  0
Pulmonary oedema  1  1/533 (0.19%)  1 0/265 (0.00%)  0
Respiratory arrest  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Vascular disorders     
Deep vein thrombosis  1  1/533 (0.19%)  1 1/265 (0.38%)  1
Embolism  1  0/533 (0.00%)  0 1/265 (0.38%)  1
Intra-Abdominal haematoma  1  0/533 (0.00%)  0 1/265 (0.38%)  1
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAS-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   506/533 (94.93%)      227/265 (85.66%)    
Blood and lymphatic system disorders     
Anaemia  1  205/533 (38.46%)  265 22/265 (8.30%)  24
Leukopenia  1  27/533 (5.07%)  34 0/265 (0.00%)  0
Neutropenia  1  152/533 (28.52%)  327 0/265 (0.00%)  0
Thrombocytopenia  1  35/533 (6.57%)  58 1/265 (0.38%)  1
Gastrointestinal disorders     
Abdominal pain  1  74/533 (13.88%)  83 32/265 (12.08%)  32
Abdominal pain upper  1  38/533 (7.13%)  40 12/265 (4.53%)  15
Constipation  1  81/533 (15.20%)  87 40/265 (15.09%)  42
Diarrhoea  1  167/533 (31.33%)  240 33/265 (12.45%)  39
Nausea  1  256/533 (48.03%)  410 63/265 (23.77%)  73
Stomatitis  1  42/533 (7.88%)  54 16/265 (6.04%)  17
Vomiting  1  142/533 (26.64%)  217 38/265 (14.34%)  57
General disorders     
Asthenia  1  96/533 (18.01%)  116 29/265 (10.94%)  29
Fatigue  1  185/533 (34.71%)  227 60/265 (22.64%)  64
Mucosal inflammation  1  30/533 (5.63%)  37 12/265 (4.53%)  13
Oedema peripheral  1  52/533 (9.76%)  57 27/265 (10.19%)  27
Pyrexia  1  93/533 (17.45%)  115 36/265 (13.58%)  40
Investigations     
Alanine aminotransferase increased  1  25/533 (4.69%)  31 14/265 (5.28%)  14
Aspartate aminotransferase increased  1  30/533 (5.63%)  33 21/265 (7.92%)  22
Blood alkaline phosphatase increased  1  47/533 (8.82%)  48 26/265 (9.81%)  26
Blood bilirubin increased  1  44/533 (8.26%)  59 18/265 (6.79%)  19
Neutrophil count decreased  1  148/533 (27.77%)  417 1/265 (0.38%)  12
Platelet count decreased  1  81/533 (15.20%)  172 6/265 (2.26%)  6
Weight decreased  1  40/533 (7.50%)  44 27/265 (10.19%)  27
White blood cell count decreased  1  146/533 (27.39%)  354 1/265 (0.38%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  206/533 (38.65%)  276 76/265 (28.68%)  81
Hyponatraemia  1  15/533 (2.81%)  16 14/265 (5.28%)  14
Musculoskeletal and connective tissue disorders     
Back pain  1  39/533 (7.32%)  41 18/265 (6.79%)  18
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  1  28/533 (5.25%)  30 20/265 (7.55%)  21
Nervous system disorders     
Dysgeusia  1  36/533 (6.75%)  42 6/265 (2.26%)  6
Headache  1  29/533 (5.44%)  32 13/265 (4.91%)  14
Psychiatric disorders     
Insomnia  1  24/533 (4.50%)  24 25/265 (9.43%)  25
Respiratory, thoracic and mediastinal disorders     
Cough  1  56/533 (10.51%)  61 30/265 (11.32%)  32
Dyspnoea  1  54/533 (10.13%)  59 28/265 (10.57%)  28
Skin and subcutaneous tissue disorders     
Alopecia  1  36/533 (6.75%)  36 3/265 (1.13%)  3
Vascular disorders     
Hypertension  1  19/533 (3.56%)  23 14/265 (5.28%)  14
1
Term from vocabulary, MedDRA (16.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Taiho agreements vary with individual investigators, but do not prohibit any from publishing. Taiho is provided time to review material discussing trial results (generally 30 to 120 days with possible extension), and can remove undisclosed confidential, proprietary and intellectual property rights-related information. Authors have final control and approval of publication content of final study results. The investigator agrees not to publish any results before the first multicenter publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development Head
Organization: Taiho Oncology, Inc.
Phone: 609 750 5300
Layout table for additonal information
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT01607957     History of Changes
Other Study ID Numbers: TPU-TAS-102-301
2012-000109-66 ( EudraCT Number )
First Submitted: May 24, 2012
First Posted: May 30, 2012
Results First Submitted: April 1, 2019
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019