Trial Outcomes & Findings for Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer (NCT NCT00824161)
NCT ID: NCT00824161
Last Updated: 2012-04-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
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.
Results posted on
2012-04-23
Participant Flow
Patients with chemotherapy-refractory advanced colorectal cancer have been recruited at 3 study sites in US between January 2009 and November 2009.
No screening period.
Participant milestones
| Measure |
TAS-109
TAS-109 2.0 mg/m\^2/day
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
TAS-109
TAS-109 2.0 mg/m\^2/day
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
TAS-109
n=28 Participants
TAS-109 2.0 mg/m\^2/day
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Age Continuous
|
55.8 years
STANDARD_DEVIATION 10.19 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Analysis was Intent to treatment(ITT) population.
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.
Outcome measures
| Measure |
TAS-109
n=28 Participants
TAS-109 2.0 mg/m\^2/day Independent Assessment
|
|---|---|
|
Percentage of Progression Free Survival
|
75.0 percentage of PFS patients
Interval 55.1 to 89.3
|
SECONDARY outcome
Timeframe: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.Population: Intent to treatment(ITT)
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.
Outcome measures
| Measure |
TAS-109
n=28 Participants
TAS-109 2.0 mg/m\^2/day Independent Assessment
|
|---|---|
|
Antitumor Activity
|
0 percentage of CR plus PR patients
95% Confidence Interval 0 • Interval 0.0 to 12.3
|
SECONDARY outcome
Timeframe: From the initial treatment until 12 months after enrollment of the last patient.Population: Analysis was Intent to Treat(ITT) population.
Overall survival is defined as the period from the date of first dose of TAS-109 to death date.
Outcome measures
| Measure |
TAS-109
n=28 Participants
TAS-109 2.0 mg/m\^2/day Independent Assessment
|
|---|---|
|
Overall Survival
|
5.5 months
Interval 3.7 to
As this study was terminated on the way, the upper bound of 95% CI was not calculated.
|
Adverse Events
TAS-109
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAS-109
n=26 participants at risk
TAS-109 2.0 mg/m\^2/day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Disease progression
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Infections and infestations
Catheter bacteremia
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
Other adverse events
| Measure |
TAS-109
n=26 participants at risk
TAS-109 2.0 mg/m\^2/day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.9%
7/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.4%
4/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.3%
11/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Cardiac disorders
Tachycardia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.4%
4/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Ascites
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Constipation
|
23.1%
6/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
8/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Proctalgia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Gastrointestinal disorders
Vomiting
|
26.9%
7/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Chills
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Disease Progression
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Fatigue
|
53.8%
14/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Oedema Peripheral
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
General disorders
Pyrexia
|
15.4%
4/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Hepatobiliary disorders
Hepatomegaly
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Hepatobiliary disorders
Jaundice
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Infections and infestations
Pneumonia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Investigations
Haemoglobin Decreased
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
8/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.4%
4/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Nervous system disorders
Headache
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.5%
3/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
6/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Vascular disorders
Deep Vein Thrombosis
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
|
Vascular disorders
Hypotension
|
7.7%
2/26 • Patients were monitored for any adverse events from the time of signed Informed Consent Form through 30 days post study medication.
|
Additional Information
Scott Kopetz, MD
The University of Texas M.D. Anderson Cancer Center
Phone: 713-792-2828
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place