NCT03306394

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Trifluridine/Tipiracil hydrochloride (S95005)

Timeline

• Start date: 2016-10-18
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2017-10-11
• Last updated: 2024-07-25

Locations

99 sites across 16 countries: Australia, Belgium, Brazil, Bulgaria, Croatia, France, Ireland, Italy, Panama, Poland, Portugal, Romania, Slovakia, Slovenia, Turkey (Türkiye), Ukraine