Advanced Colorectal Cancer
Conditions
Brief summary
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
Interventions
DRUGTAS-109
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.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed colorectal adenocarcinoma * Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan * Have at least one measurable tumor, as defined by RECIST * Must be capable of maintaining a central venous line access
Exclusion criteria
* Had previous anti-tumor therapy in the 3 weeks prior to study entry * Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry * Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Progression Free Survival | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor Activity | From the date of initial treatment until the date of the first objective documentation of PD or death from any cause. | 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. |
| Overall Survival | From the initial treatment until 12 months after enrollment of the last patient. | Overall survival is defined as the period from the date of first dose of TAS-109 to death date. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| TAS-109 TAS-109 2.0 mg/m\^2/day | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TAS-109 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 55.8 years STANDARD_DEVIATION 10.19 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 9 / 26 |
Outcome results
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.
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.
Population: Analysis was Intent to treatment(ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAS-109 | Percentage of Progression Free Survival | 75.0 percentage of PFS patients |
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| TAS-109 | Antitumor Activity | 0 percentage of CR plus PR patients | 95% Confidence Interval 0 |
Secondary
Overall Survival
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.
Population: Analysis was Intent to Treat(ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAS-109 | Overall Survival | 5.5 months |