Colorectal CancerPhase 1NCT03974594
Bioequivalence Study of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients
A Phase 1 study testing Trifluridine and Tipiracil Tablets and TAS-102 in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Trifluridine and Tipiracil Tablets and TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2019to 16 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital,Fourth Military Medical University
Xi’an, Shanxi, 710038
About this study
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
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
- Being tested
- Trifluridine and Tipiracil Tablets, TAS-102
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine and Tipiracil TabletsDrug
Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle
TAS-102Drug
TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
| Study group | Role | What they receive |
|---|---|---|
| Trifluridine and Tipiracil Tablets | Experimental | Not described Receives: Drug: Trifluridine and Tipiracil Tablets |
| TAS-102 | Active comparator | Not described Receives: Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-infinity)
The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.
Measured: 3 days
AUC(0-t)
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
Measured: 3 days
Bioequivalence based on Peak Plasma Concentration (Cmax)
The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile
Measured: 3 days
Secondary outcomes (1)
Adverse Event
Security Index
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start21 May 2019
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974594
- Sponsor's protocol ID
- CTTQ-TAS-102-I-02
- Status last verified
- Apr 2022
- First submitted
- 31 May 2019
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36622402
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03974594
- Acronym / sponsor ID
- CTTQ-TAS-102-I-02
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trifluridine and Tipiracil Tablets | Experimental | Drug: Trifluridine and Tipiracil Tablets |
| TAS-102 | Active comparator | Drug: TAS-102 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (20 listed)
- Has serious diseases , including but not limited to:
- Has received any of the following treatments before the first dose:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine and Tipiracil TabletsTrifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle | Drug | Trifluridine and Tipiracil Tablets |
| TAS-102TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle | Drug | TAS-102 |
Primary outcome
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.
AUC(0-t)
Time frame: 3 days
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
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
1 secondary outcome
Adverse Event
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Derived from this study: PubMed 36622402Su 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trifluridine and Tipiracil Tablets and TAS-102 in people with Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-infinity) (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.