Clinical trial · Interventional
A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).
An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trifluridine/Tipiracil hydrochloride (S95005) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S95005
- description
- Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
- interventionNames
- Drug: Trifluridine/Tipiracil hydrochloride (S95005)
Primary outcomes (4)
- measure
- Incidence of Adverse Events [safety and tolerability]
- timeFrame
- Through 28 days following last administration of study medication
- measure
- Abnormalities in laboratory assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or Female participant aged ≥18 years old. * Has definitive histologically confirmed adenocarcinoma of the colon or rectum. * Has metastatic lesion(s). * Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period. * Is able to take medications orally (i.e., no feeding tube). * Has adequate organ function. * Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method. Exclusion Criteria: * Pregnancy, breastfeeding or possibility of becoming pregnant during the study. * Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil. * Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil. * Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. * Has certain serious illness or medical condition(s) described in the protocol. * Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration. * Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
References
Publications (4)
- BACKGROUNDBachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698. PMID 32487542
- DERIVEDTaieb J, Price T, Vidot L, Chevallier B, Wyrwicz L, Bachet JB. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy. BMC Cancer. 2023 Jan 27;23(1):94. doi: 10.1186/s12885-022-10489-4. PMID 36707808
- DERIVEDOzet A, Dane F, Aykan NF, Yalcin S, Evrensel T, Ozkan M, Karabulut B, Ormeci MN, Atasev O, Vidot L, Cicin I. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey. Future Oncol. 2022 Sep;18(29):3267-3276. doi: 10.2217/fon-2022-0455. Epub 2022 Aug 30. PMID 36040321
- DERIVEDZaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5. PMID 33663264