Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Trifluridine and Tipiracil Tablets
TAS-102
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old, life expectancy ≥ 3 months.
- Histologically confirmed colon or rectal adenocarcinoma.
- Has not received anti-tumor therapy before 4 weeks of first dose or Traditional Chinese Medicine anti-tumor therapy before 2 weeks of first dose.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has ability to take oral medication.
The main organs function are normally, the following criteria are met:
- Hemoglobin (HB) ≥ 100 g / L;
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelets (PLT) ≥ 80 × 109 / L;
- Total serum bilirubin (TBIL) ≤ 1.5 × ULN;
- Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN (when the liver is invaded,AST ≤ 5×ULN);
- Serum creatinine ≤ 132.6 μmol / L.
- Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- Understood and signed an informed consent form.
Exclusion Criteria:
Has serious diseases , including but not limited to:
- Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include carcinoma in situ of cervix, non-melanoma skin cancer and superficial bladder tumor;
- Has brain metastases;
- Has active infection (such as infection caused body temperature ≥ 38 ° C);
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage before 4 weeks of first dose;
- Has intestinal obstruction, pulmonary fibrosis, renal failure, liver failure or symptomatic cerebrovascular disease;
- Has uncontrolled diabetes (fasting blood glucose (FBG) > 10mmol/L);
- Has myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure within 12 months prior to first dose;
- Has gastrointestinal bleeding;
- Has HIV infection, or active hepatitis B or C;
- Has a history of organ transplants or autoimmune disease required immunosuppressive therapy;
- Has increased risk associated with participating in the study or taking the study drug, or mental disorders may interfere with the results of the study.
Has received any of the following treatments before the first dose:
- Has received partial or total gastrectomy;
- Has surgery (such as laparotomy, thoracotomy, and laparoscopic resection of the viscera and/or unhealed wounds) within 4 weeks;
- Has any study drug within 4 weeks.
- Prior therapy with TAS-102.
- Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 2.
- Pregnant or lactating woman.
- Subjects who, in the opinion of the investigators, should not participate in the study.
Sites / Locations
- Tangdu Hospital,Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trifluridine and Tipiracil Tablets
TAS-102
Arm Description
Outcomes
Primary Outcome Measures
AUC(0-infinity)
The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.
AUC(0-t)
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
Bioequivalence based on Peak Plasma Concentration (Cmax)
The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile
Secondary Outcome Measures
Adverse Event
Security Index
Full Information
NCT ID
NCT03974594
First Posted
May 31, 2019
Last Updated
April 12, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03974594
Brief Title
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
Official Title
Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients Under Fasting or Postprandial Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Trifluridine and Tipiracil Tablets is a nucleoside anti-metabolic and anti-cancer compound developed by Taiho (Dapeng) Co., Ltd., Japan, for the treatment of advanced colorectal cancer that inoperable resection, and progressed or relapsed after standard treatment. This study mainly evaluates bioequivalence, safety and tolerance of Trifluridine and Tipiracil Tablets in colorectal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trifluridine and Tipiracil Tablets
Arm Type
Experimental
Arm Title
TAS-102
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Trifluridine and Tipiracil Tablets
Intervention Description
Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle
Intervention Type
Drug
Intervention Name(s)
TAS-102
Intervention Description
TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
Primary Outcome Measure Information:
Title
AUC(0-infinity)
Description
The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.
Time Frame
3 days
Title
AUC(0-t)
Description
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
Time Frame
3 days
Title
Bioequivalence based on Peak Plasma Concentration (Cmax)
Description
The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Adverse Event
Description
Security Index
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years old, life expectancy ≥ 3 months.
Histologically confirmed colon or rectal adenocarcinoma.
Has not received anti-tumor therapy before 4 weeks of first dose or Traditional Chinese Medicine anti-tumor therapy before 2 weeks of first dose.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Has ability to take oral medication.
The main organs function are normally, the following criteria are met:
Hemoglobin (HB) ≥ 100 g / L;
Absolute neutrophil count (ANC) ≥1.5×109/L;
Platelets (PLT) ≥ 80 × 109 / L;
Total serum bilirubin (TBIL) ≤ 1.5 × ULN;
Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN (when the liver is invaded,AST ≤ 5×ULN);
Serum creatinine ≤ 132.6 μmol / L.
Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
Understood and signed an informed consent form.
Exclusion Criteria:
Has serious diseases , including but not limited to:
Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include carcinoma in situ of cervix, non-melanoma skin cancer and superficial bladder tumor;
Has brain metastases;
Has active infection (such as infection caused body temperature ≥ 38 ° C);
Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage before 4 weeks of first dose;
Has intestinal obstruction, pulmonary fibrosis, renal failure, liver failure or symptomatic cerebrovascular disease;
Has uncontrolled diabetes (fasting blood glucose (FBG) > 10mmol/L);
Has myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure within 12 months prior to first dose;
Has gastrointestinal bleeding;
Has HIV infection, or active hepatitis B or C;
Has a history of organ transplants or autoimmune disease required immunosuppressive therapy;
Has increased risk associated with participating in the study or taking the study drug, or mental disorders may interfere with the results of the study.
Has received any of the following treatments before the first dose:
Has received partial or total gastrectomy;
Has surgery (such as laparotomy, thoracotomy, and laparoscopic resection of the viscera and/or unhealed wounds) within 4 weeks;
Has any study drug within 4 weeks.
Prior therapy with TAS-102.
Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 2.
Pregnant or lactating woman.
Subjects who, in the opinion of the investigators, should not participate in the study.
Facility Information:
Facility Name
Tangdu Hospital,Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
12. IPD Sharing Statement
Learn more about this trial
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
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