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Clinical Trial Finder

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

Program Status

Active, not recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Placebo, Trilaciclib

Tags

MSS/ pMMR
Location Location Status
United States
AZ Oncology Associates - HOPE
Tucson, Arizona 85711
Active, not recruiting
Beverly Hills Cancer Center
Beverly Hills, California 90211
Active, not recruiting
Keck Medical Center of USC Pasadena
Los Angeles, California 90033
Active, not recruiting
The Oncology Institute of Hope & Innovation Innovative Clinical Research Institute
Whittier, California 90603
Active, not recruiting
Georgetown University - Lombardi Comprehensive Cancer Center
Washington, District of Columbia 20007
Active, not recruiting
Florida Cancer Specialists (South Region)
Fort Myers, Florida 33916
Active, not recruiting
Florida Cancer Specialists NORTH
Fort Myers, Florida 33916
Active, not recruiting
Mid-Florida Hematology & Oncology Centers, P.A.
Orange City, Florida 32763
Active, not recruiting
Florida Cancer Specialists
Saint Petersburg, Florida 33705
Active, not recruiting
Florida Cancer Specialists - Panhandle
Tallahassee, Florida 32308
Active, not recruiting
Northside Hospital - Georgia Cancer Specialists
Atlanta, Georgia 30342
Active, not recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
Active, not recruiting
Boston Medical Center
Boston, Massachusetts 02118
Active, not recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
Active, not recruiting
Mayo Clinic - Rochester
Rochester, Minnesota 55905
Active, not recruiting
Comp. Cancer Centers of Nevada
Las Vegas, Nevada 89169
Active, not recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Active, not recruiting
Oregon Health & Science University
Portland, Oregon 97239
Active, not recruiting
Gettysburg Cancer Center
Gettysburg, Pennsylvania 17325
Active, not recruiting
Tennessee Oncology
Nashville, Tennessee 37203
Active, not recruiting
UT Southwestern Medical Center
Dallas, Texas 75390
Active, not recruiting
Millennium Oncology
Kingswood, Texas 77339
Active, not recruiting
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Active, not recruiting
Onc and Hem Assoc of SW VA
Roanoke, Virginia 24014
Active, not recruiting
China
Henan Cancer Hospital
Zijingshan, Henan
Active, not recruiting
Wuhan Union Hospital
Wuhan, Hubei
Active, not recruiting
Jilin Provincial Tumor Hospital
Changchun, Jilin
Active, not recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Active, not recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Active, not recruiting
The Affiliated Tumor Hospital of Harbin Medical University
Heilongjiang
Active, not recruiting
Jinan Central hospital
Shandong
Active, not recruiting
Zhongshan Hospital Fudan University
Shanghai 200032
Active, not recruiting
Xuzhou Central hospital
Xuzhou
Active, not recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou
Active, not recruiting
Hungary
Orszagos Onkologiai Intezet
Budapest 1122
Active, not recruiting
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula 5700
Active, not recruiting
Bacs-Kiskun Megyei Oktatokorhaz
Kecskemet 6000
Active, not recruiting
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza 4400
Active, not recruiting
Italy
ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato)
Casale Monferrato, Alessandria 15033
Active, not recruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Roma 00133
Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Roma 00168
Active, not recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Cremona 26100
Active, not recruiting
Azienda Ospedaliera Universitaria Careggi
Firenze 50141
Active, not recruiting
Poland
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
Gdynia 81-519
Active, not recruiting
Szpital Specjalistyczny im. L.Rydygiera w Krakowie
Krakow 31-637
Active, not recruiting
Mrukmed Lekarz Beata Madej Mruk i Partner Spółka Partnerska Oddział nr 1 w Rzeszowie
Rzeszów 35-922
Active, not recruiting
Centrum Medyczne Pratia Poznan
Skórzewo 60-185
Active, not recruiting
Centrum Zdrowia MDM
Warszawa 00-635
Active, not recruiting
Spain
Hospital Universitari Vall d'Hebron
Barcelona 08035
Active, not recruiting
Hospital Clinic de Barcelona
Barcelona 08036
Active, not recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona 08907
Active, not recruiting
Hospital Universitari Arnau de Vilanova
Lleida 25198
Active, not recruiting
Hospital Universitario Lucus Augsti
Lugo 27003
Active, not recruiting
Hospital General Universitario Gregorio Marañon
Madrid 28007
Active, not recruiting
Hospital Universitario Ramon y Cajal
Madrid 28034
Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid 28041
Active, not recruiting
Hospital Universitario La Paz
Madrid 28046
Active, not recruiting
Hospital Universitario HM Madrid Sanchinarro
Madrid 28050
Active, not recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid 28222
Active, not recruiting
Hospital Universitario Virgen Macarena
Sevilla 41009
Active, not recruiting
Hospital Universitario Virgen del Rocio
Sevilla 41013
Active, not recruiting
Hospital Clinico Universitario de Valencia
Valencia 46010
Active, not recruiting
Hospital Universitario Miguel Servet
Zaragoza 50009
Active, not recruiting
Ukraine
CI Cherkasy Regional Oncological Dispensary of CRC
Cherkasy 18009
Active, not recruiting
MI Regional Clinical Oncologycal Dispensary
Dnipro 49100
Active, not recruiting
Dnipropetrovsk City Multispecialty Clinical Hospital #4
Dnipro 49102
Active, not recruiting
Limited Liability Company "Medical Center named by Academician Yuriy Prokopovich Spizhenko"
Kapitanivka 8112
Active, not recruiting
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
Kharkiv 61037
Active, not recruiting
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU
Kharkiv 61070
Active, not recruiting
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi
Active, not recruiting
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih 50048
Active, not recruiting
Medical Center Asklepion LLC
Kyiv
Active, not recruiting
Medical Center of Limited Liability Company Medical Center Concilium Medical
Kyiv
Active, not recruiting
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
Lutsk 43018
Active, not recruiting
Communal Institution Odesa Regional Clinical Hospital; Department of Surgery
Odesa 65025
Active, not recruiting
University Hospital of Sumy State University
Sumy 40022
Active, not recruiting
CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU
Uzhgorod
Active, not recruiting
Medical center "Oncolife" LLC
Zaporizhzhia 69059
Active, not recruiting
United Kingdom
Barts Hospital
London, Greater London EC1A 7BE
Active, not recruiting
Royal Free Hospital
London, Greater London NW3 2QG
Active, not recruiting
The Christie
Manchester, Greater Manchester M20 4BX
Active, not recruiting
Velindre Cancer Centre
Cardiff, South Glamorgan CF14 2TL
Active, not recruiting

Inclusion Criteria

Selected Inclusion Criteria:

Age ≥ 18 years of age at the time of signing the informed consent. Patients > 70 years of age must have a G8 Health State Screening Tool (geriatric screening tool) score >.
Proficient mismatch repair/microsatellite stable (pMMR/MSS), histologically or cytologically-confirmed adenocarcinoma of the colon or rectum. Patients with any BRAF or KRAS mutation status are eligible.
Unresectable and measurable or evaluable disease per RECIST v1.1
ECOG performance status of 0 to 1
A formalin-fixed paraffin-embedded (FFPE) tumor specimen (from archival or fresh biopsy) with an associated pathology report documenting pMMR/MSS mCRC must be confirmed to be available to send to the Sponsor for planned retrospective biomarker analyses.
Adequate organ function

Selected

Exclusion Criteria

Exclusion Criteria:

Prior systemic therapy for mCRC. Patients who received adjuvant/neoadjuvant therapy (ie, treatment with curative intent) for colorectal cancer are eligible if it has been ≥ 6 months between the last dose of systemic chemotherapy and the date of informed consent.
Any radiotherapy, chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment (except for adjuvant hormonal therapy for breast cancer or prostate cancer defined as M0 disease or PSA persistence/recurrence without metastatic disease) within 3 weeks prior to the first dose of trilaciclib/placebo.
Receipt of any low-dose systemic chemotherapeutic agent (e.g., low-dose methotrexate for rheumatoid arthritis) administered for a nononcologic purpose within 3 weeks prior to the first dose of trilaciclib/placebo.
Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
QTcF interval > 450 msec (males) or > 470 msec (females) at screening. For patients with ventricular pacemakers, QTcF > 500 msec.
Personal or family history of long QT syndrome
Symptomatic peripheral neuropathy
History of interstitial lung disease (ILD)
Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation

NCT ID

NCT04607668

Date Trial Added

2020-10-29

Updated Date

2022-09-07