Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: Trifluridine and Tipiracil Tablets Drug: TAS-102 | Phase 1 |
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 |
Arm | Intervention/treatment |
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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
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Active Comparator: TAS-102 |
Drug: TAS-102
TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
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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 |
Inclusion Criteria:
The main organs function are normally, the following criteria are met:
Exclusion Criteria:
Has serious diseases , including but not limited to:
Has received any of the following treatments before the first dose:
Contact: Helong Zhang, Doctor | 135 1912 8910 | cntdccc@126.com |
China, Shanxi | |
Tangdu Hospital,Fourth Military Medical University | Recruiting |
Xi'an, Shanxi, China, 710038 | |
Contact: Helong Zhang, Doctor 135 1912 8910 cntdccc@126.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 31, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Actual Study Start Date ICMJE | May 22, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Adverse Event [ Time Frame: Up to 4 weeks ] Security Index
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03974594 | ||||
Other Study ID Numbers ICMJE | CTTQ-TAS-102-I-02 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Study Sponsor ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |