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Terminated Phase 3 Interventional Results available

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):

ClinicalTrials.gov ID: NCT04607668

Public ClinicalTrials.gov record NCT04607668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:41 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04607668
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
G1 Therapeutics, Inc.
Industry
Enrollment
326 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 6, 2021 (Actual)
Primary completion
Feb 13, 2023 (Actual)
Completion
Mar 31, 2023 (Actual)
Last update posted
Nov 26, 2024

2021 – 2023

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
23
Facility City State ZIP Site status
AZ Oncology Associates - HOPE Tucson Arizona 85711 —
Beverly Hills Cancer Center Beverly Hills California 90211 —
Keck Medical Center of USC Pasadena Los Angeles California 90033 —
The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute Whittier California 90603 —
Georgetown University - Lombardi Comprehensive Cancer Center Washington D.C. District of Columbia 20007 —
Florida Cancer Specialists (South Region) Fort Myers Florida 33916 —
Florida Cancer Specialists NORTH Fort Myers Florida 33916 —
Mid-Florida Hematology & Oncology Centers, P.A. Orange City Florida 32763 —
Florida Cancer Specialists St. Petersburg Florida 33705 —
Florida Cancer Specialists - Panhandle Tallahassee Florida 32308 —
Northside Hospital - Georgia Cancer Specialists Atlanta Georgia 30342 —
Illinois Cancer Specialists Arlington Heights Illinois 60005 —
Boston Medical Center Boston Massachusetts 02118 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655 —
Mayo Clinic - Rochester Rochester Minnesota 55905 —
Comp. Cancer Centers of Nevada Las Vegas Nevada 89169 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Oregon Health & Science University Portland Oregon 97239 —
Gettysburg Cancer Center Gettysburg Pennsylvania 17325 —
Tennessee Oncology Nashville Tennessee 37203 —
UT Southwestern Medical Center Dallas Texas 75390 —
Millennium Oncology Kingswood Texas 77339 —
Inova Schar Cancer Institute Fairfax Virginia 22031 —
Onc and Hem Assoc of SW VA Roanoke Virginia 24014 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04607668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 26, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04607668 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →