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NCT05223673 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Institut de Recherches Internationales Servier.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT05223673 is a Phase 3 study that was terminated before completion, run by Institut de Recherches Internationales Servier. The registered enrollment target is 7 participants.
The verdict
NCT05223673, a Phase 3 study, was terminated before completion, sponsored by Institut de Recherches Internationales Servier.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).
Interventions
- DRUG Trifluridine/Tipiracil
- BIOLOGICAL Futuximab/modotuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-04-21 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05223673
The ClinicalTrials.gov registry entry for NCT05223673 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trifluridine/Tipiracil is the first listed.
NCT05223673 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05223673 about?
NCT05223673 is a clinical study titled "Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer". This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the saf...
What is the current status of trial NCT05223673?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2022-04-21. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05223673?
The interventions under investigation include: Trifluridine/Tipiracil (DRUG), Futuximab/modotuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05223673?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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