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NCT04737187 · ClinicalTrials.gov registry record · Phase 3

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

A Phase 3 study of Refractory Metastatic Colorectal Cancer, sponsored by Taiho Oncology.

Completed
Registry status
Phase 3
Development phase
492
Enrollment target
20
Study locations

NCT04737187: Completed Phase 3 study of Refractory Metastatic Colorectal Cancer, sponsored by Taiho Oncology.

NCT04737187 is a Phase 3 study of Refractory Metastatic Colorectal Cancer that has completed, run by Taiho Oncology. The registered enrollment target is 492 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04737187, a Phase 3 study of Refractory Metastatic Colorectal Cancer, has completed, sponsored by Taiho Oncology.

COMPLETED
Registry status
Phase 3
Development phase
492 participants
Enrollment target
20
Study locations

Study Summary

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Primary Outcome

Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method.

Interventions

  • DRUG Bevacizumab
  • DRUG Trifluridine/Tipiracil

Study Locations (20)

Other

  • "Medizinische Universität Graz " - Graz
  • "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V" - Innsbruck
  • "Ordensklinikum Linz Barmherzige Schwestern Interne I" - Linz
  • "Landeskrankenhaus Feldkirch Interne E" - Rankweil
  • "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)" - Salzburg
  • "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie" - Vienna
  • "Landesklinikum Wiener Neustadt " - Wiener Neustadt
  • "OLV Ziekenhuis Oncology" - Aalst

California

  • City of Hope - Duarte
  • City of Hope - South Pasedena - South Pasadena
  • City of Hope - Upland - Upland

Florida

  • Mayo Clinic - FL - Jacksonville
  • Mount Sinai Comprehensive Cancer Center - Miami Beach
  • Comprehensive Hematology Oncology - St. Petersburg

Arizona

  • Mayo Clinic Hospital - Phoenix

Illinois

  • DuPage Medical Group - Joliet Oncology-Hematology Associates - Joliet

Indiana

  • Investigative Clinical Research of Indiana LLC - Noblesville

Nebraska

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Omaha

New York

  • Mayo Clinic - Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 492 participants
Start Date 2020-11-25
Est. Completion 2023-09-12
Phase Phase 3
Taiho Oncology

52 total trials

What the finished NCT04737187 record still lists

NCT04737187 is an interventional study that assigns participants to a tested intervention. The registered 492 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).

The record links to 1 condition, with Refractory Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.

NCT04737187 names 20 study sites across 9 states, led by Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04737187 about?

NCT04737187 is a clinical study titled "Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients". This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

What is the current status of trial NCT04737187?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 492 participants. The study started on 2020-11-25. Estimated completion is 2023-09-12.

What conditions does trial NCT04737187 study?

This clinical trial studies the following conditions: Refractory Metastatic Colorectal Cancer.

What interventions are being tested in trial NCT04737187?

The interventions under investigation include: Bevacizumab (DRUG), Trifluridine/Tipiracil (DRUG).

Who is sponsoring clinical trial NCT04737187?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04737187 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Refractory Metastatic Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04737187's enrollment target sits among peer trials

492 780th of 2000 higher than 1,220 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04737187, the US trial registry maintained by the National Library of Medicine. NCT04737187 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.