Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

NCT03974594 | Completed Phase 1

• 1 other identifier: CTTQ-TAS-102-I-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• AUC(0-infinity)

  The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.

  3 days

• AUC(0-t)

  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)

  The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile

  3 days

Secondary Outcomes (1)

• Adverse Event

  Up to 4 weeks

Study Arms (2)

Trifluridine and Tipiracil Tablets

EXPERIMENTAL

Drug: Trifluridine and Tipiracil Tablets

TAS-102

ACTIVE COMPARATOR

Drug: TAS-102

Interventions

Trifluridine and Tipiracil Tablets DRUG

Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle

Trifluridine and Tipiracil Tablets

TAS-102 DRUG

TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle

TAS-102

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Tangdu Hospital,Fourth Military Medical University

Xi’an, Shanxi, 710038, China

Location

Related Publications (1)

• Su HC, Min J, Song Y, Liu LL, Liu LN, Zhang HL. A bioequivalence study of trifluridine/tipiracil tablets in Chinese metastatic colorectal cancer patients under fed conditions. Cancer Chemother Pharmacol. 2023 Feb;91(2):167-177. doi: 10.1007/s00280-022-04501-8. Epub 2023 Jan 9.

  PMID: 36622402 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridine; tipiracil; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: May 21, 2019
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)