- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974594
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
April 12, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Xi'an, Shanxi, China, 710038
- Tangdu hospital,fourth military medical university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Trifluridine and Tipiracil Tablets
|
Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle
|
ACTIVE_COMPARATOR: TAS-102
|
TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC(0-infinity)
Time Frame: 3 days
|
The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.
|
3 days
|
AUC(0-t)
Time Frame: 3 days
|
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
|
3 days
|
Bioequivalence based on Peak Plasma Concentration (Cmax)
Time Frame: 3 days
|
The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event
Time Frame: Up to 4 weeks
|
Security Index
|
Up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 21, 2019
Primary Completion (ACTUAL)
July 16, 2019
Study Completion (ACTUAL)
July 16, 2019
Study Registration Dates
First Submitted
May 31, 2019
First Submitted That Met QC Criteria
May 31, 2019
First Posted (ACTUAL)
June 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 12, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Trifluridine
Other Study ID Numbers
- CTTQ-TAS-102-I-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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