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Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT03974594
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Trifluridine and Tipiracil Tablets Drug: TAS-102 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trifluridine and Tipiracil Tablets Drug: Trifluridine and Tipiracil Tablets
Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle

Active Comparator: TAS-102 Drug: TAS-102
TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle




Primary Outcome Measures :
  1. 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.

  2. 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. 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


Secondary Outcome Measures :
  1. Adverse Event [ Time Frame: Up to 4 weeks ]
    Security Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-70 years old, life expectancy ≥ 3 months.
  2. Histologically confirmed colon or rectal adenocarcinoma.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  5. Has ability to take oral medication.
  6. The main organs function are normally, the following criteria are met:

    1. Hemoglobin (HB) ≥ 100 g / L;
    2. Absolute neutrophil count (ANC) ≥1.5×109/L;
    3. Platelets (PLT) ≥ 80 × 109 / L;
    4. Total serum bilirubin (TBIL) ≤ 1.5 × ULN;
    5. Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN (when the liver is invaded,AST ≤ 5×ULN);
    6. Serum creatinine ≤ 132.6 μmol / L.
  7. 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.
  8. Understood and signed an informed consent form.

Exclusion Criteria:

  1. Has serious diseases , including but not limited to:

    1. 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;
    2. Has brain metastases;
    3. Has active infection (such as infection caused body temperature ≥ 38 ° C);
    4. Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage before 4 weeks of first dose;
    5. Has intestinal obstruction, pulmonary fibrosis, renal failure, liver failure or symptomatic cerebrovascular disease;
    6. Has uncontrolled diabetes (fasting blood glucose (FBG) > 10mmol/L);
    7. 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;
    8. Has gastrointestinal bleeding;
    9. Has HIV infection, or active hepatitis B or C;
    10. Has a history of organ transplants or autoimmune disease required immunosuppressive therapy;
    11. 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.
  2. Has received any of the following treatments before the first dose:

    1. Has received partial or total gastrectomy;
    2. Has surgery (such as laparotomy, thoracotomy, and laparoscopic resection of the viscera and/or unhealed wounds) within 4 weeks;
    3. Has any study drug within 4 weeks.
  3. Prior therapy with TAS-102.
  4. Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade 2.
  5. Pregnant or lactating woman.
  6. Subjects who, in the opinion of the investigators, should not participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974594


Contacts
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Contact: Helong Zhang, Doctor 135 1912 8910 cntdccc@126.com

Locations
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China, Shanxi
Tangdu Hospital,Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710038
Contact: Helong Zhang, Doctor    135 1912 8910    cntdccc@126.com   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03974594     History of Changes
Other Study ID Numbers: CTTQ-TAS-102-I-02
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents