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Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
NCT04737187 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 492 participants |
| Start Date | 2020-11-25 |
| Est. Completion | 2023-09-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04737187
The ClinicalTrials.gov registry entry for NCT04737187 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 492 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Taiho Oncology, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04737187 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04737187?
The interventions under investigation include: Bevacizumab (DRUG), Trifluridine/Tipiracil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04737187?
This trial is sponsored by Taiho Oncology, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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