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

PHASE3TerminatedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

January 6, 2021

Primary Completion Date

February 13, 2023

Study Completion Date

March 31, 2023

Conditions
Colorectal Cancer MetastaticMyelosuppression-AdultChemotherapeutic Toxicity
Interventions
DRUG

Trilaciclib

Trilaciclib diluted in dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over approximately 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of trilaciclib was administered on Day 2.

DRUG

Placebo

Dextrose 5% in water or normal saline (sodium chloride solution 0.9%) administered by IV infusion over 30 (±10) minutes no more than 4 hours prior to each Day 1 chemotherapy administration. Second dose of placebo was administered on Day 2.

Trial Locations (82)

1122

Orszagos Onkologiai Intezet, Budapest

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

6000

Bacs-Kiskun Megyei Oktatokorhaz, Kecskemét

8112

"Limited Liability Company Medical Center named by Academician Yuriy Prokopovich Spizhenko", Kapitanivka

15033

ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato), Casale Monferrato

17325

Gettysburg Cancer Center, Gettysburg

18009

CI Cherkasy Regional Oncological Dispensary of CRC, Cherkasy

20007

Georgetown University - Lombardi Comprehensive Cancer Center, Washington D.C.

22031

Inova Schar Cancer Institute, Fairfax

24014

Onc and Hem Assoc of SW VA, Roanoke

25198

Hospital Universitari Arnau de Vilanova, Lleida

26100

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Cremona

27003

Hospital Universitario Lucus Augsti, Lugo

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28050

Hospital Universitario HM Madrid Sanchinarro, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

30342

Northside Hospital - Georgia Cancer Specialists, Atlanta

32308

Florida Cancer Specialists - Panhandle, Tallahassee

32763

Mid-Florida Hematology & Oncology Centers, P.A., Orange City

33705

Florida Cancer Specialists, St. Petersburg

33916

Florida Cancer Specialists (South Region), Fort Myers

Florida Cancer Specialists NORTH, Fort Myers

37203

Tennessee Oncology, Nashville

40022

University Hospital of Sumy State University, Sumy

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

43018

Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council, Lutsk

46010

Hospital Clinico Universitario de Valencia, Valencia

49100

MI Regional Clinical Oncologycal Dispensary, Dnipro

49102

Dnipropetrovsk City Multispecialty Clinical Hospital #4, Dnipro

50009

Hospital Universitario Miguel Servet, Zaragoza

50048

CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih

50141

Azienda Ospedaliera Universitaria Careggi, Florence

55905

Mayo Clinic - Rochester, Rochester

60005

Illinois Cancer Specialists, Arlington Heights

61037

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC, Kharkiv

61070

Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU, Kharkiv

65025

Communal Institution Odesa Regional Clinical Hospital; Department of Surgery, Odesa

69059

"Medical center Oncolife LLC", Zaporizhzhia

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

UT Southwestern Medical Center, Dallas

77339

Millennium Oncology, Kingswood

85711

AZ Oncology Associates - HOPE, Tucson

89169

Comp. Cancer Centers of Nevada, Las Vegas

90033

Keck Medical Center of USC Pasadena, Los Angeles

90211

Beverly Hills Cancer Center, Beverly Hills

90603

The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute, Whittier

97239

Oregon Health & Science University, Portland

200032

Zhongshan Hospital Fudan University, Shanghai

02118

Boston Medical Center, Boston

01655

University of Massachusetts Memorial Medical Center, Worcester

Unknown

Henan Cancer Hospital, Zijingshan

Wuhan Union Hospital, Wuhan

Jilin Provincial Tumor Hospital, Changchun

The First Affiliated Hospital of Zhejiang University, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

The Affiliated Tumor Hospital of Harbin Medical University, Heilongjiang

Jinan Central hospital, Shandong

Xuzhou Central hospital, Xuzhou

First Affiliated Hospital of Zhengzhou University, Zhengzhou

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus, Kropyvnytskyi

Medical Center Asklepion LLC, Kyiv

Medical Center of Limited Liability Company Medical Center Concilium Medical, Kyiv

CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU, Uzhhorod

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

81-519

Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością, Gdynia

31-637

Szpital Specjalistyczny im. L.Rydygiera w Krakowie, Krakow

35-922

Mrukmed Lekarz Beata Madej Mruk i Partner Spółka Partnerska Oddział nr 1 w Rzeszowie, Rzeszów

60-185

Centrum Medyczne Pratia Poznan, Skórzewo

00-635

Centrum Zdrowia MDM, Warsaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08907

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona

EC1A 7BE

Barts Hospital, London

NW3 2QG

Royal Free Hospital, London

M20 4BX

The Christie, Manchester

CF14 2TL

Velindre Cancer Centre, Cardiff

Sponsors
All Listed Sponsors
lead

G1 Therapeutics, Inc.

INDUSTRY

NCT04607668 - Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): | Biotech Hunter | Biotech Hunter