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NCT04607668 · ClinicalTrials.gov registry record · Phase 3
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
A Phase 3 study, sponsored by G1 Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT04607668: Clinical Trial Phase 3 study, sponsored by G1 Therapeutics.
NCT04607668 is a Phase 3 study that was terminated before completion, run by G1 Therapeutics. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04607668, a Phase 3 study, was terminated before completion, sponsored by G1 Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic disease.
Primary Outcome
The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of \< 0.5 × 10\^9/L to the date of the first ANC value ≥ 0.5 × 10\^9/L where no additional ANC values \< 0.5 × 10\^9/L were observed for the remainder of that cycle.
Interventions
- DRUG Placebo
- DRUG Trilaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 3 |
Why NCT04607668 stopped before completion
NCT04607668 is an interventional study that assigns participants to a tested intervention. The registered 326 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04607668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04607668 about?
NCT04607668 is a clinical study titled "Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):". This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for met...
What is the current status of trial NCT04607668?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2021-01-06. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT04607668?
The interventions under investigation include: Placebo (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT04607668?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04607668's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 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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