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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04607668
Other study ID # G1T28-207
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 16, 2020
Est. completion date March 31, 2023

Study information

Verified date April 2023
Source G1 Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is 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.


Description:

Patients will be randomly assigned (1:1) to receive placebo or trilaciclib on Days 1 and 2 administered intravenously (IV) prior to FOLFOXIRI/bevacizumab in 14-day cycles for up to 12 cycles (Induction). Following completion of Induction, patients will continue in Maintenance, where they will receive trilaciclib or placebo per randomization allocation at study entry. Trilaciclib/placebo will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction. The patient may continue to receive treatment on study until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation by Investigator, or the end of the trial, whichever occurs first. Treatment cycles will occur consecutively without interruption, except when necessary to manage toxicities or for administrative reasons.


Recruitment information / eligibility

Status Terminated
Enrollment 326
Est. completion date March 31, 2023
Est. primary completion date February 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Selected Inclusion Criteria: 1. 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 >. 2. 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. 3. Unresectable and measurable or evaluable disease per RECIST v1.1 4. ECOG performance status of 0 to 1 5. 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. 6. Adequate organ function Selected Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Presence of central nervous system (CNS) metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids 5. QTcF interval > 450 msec (males) or > 470 msec (females) at screening. For patients with ventricular pacemakers, QTcF > 500 msec. 6. Personal or family history of long QT syndrome 7. Symptomatic peripheral neuropathy 8. History of interstitial lung disease (ILD) 9. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation

Study Design


Intervention

Drug:
Trilaciclib
Trilaciclib or placebo
Placebo
dextrose 5% in water or normal saline (sodium chloride solution 0.9%)

Locations

Country Name City State
China Jilin Provincial Tumor Hospital Changchun Jilin
China The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China The Affiliated Tumor Hospital of Harbin Medical University Heilongjiang
China Jinan Central hospital Shandong
China Zhongshan Hospital Fudan University Shanghai
China Wuhan Union Hospital Wuhan Hubei
China Xuzhou Central hospital Xuzhou
China First Affiliated Hospital of Zhengzhou University Zhengzhou
China Henan Cancer Hospital Zijingshan Henan
Hungary Orszagos Onkologiai Intezet Budapest
Hungary Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza Gyula
Hungary Bacs-Kiskun Megyei Oktatokorhaz Kecskemet
Hungary SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Nyiregyhaza
Italy ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato) Casale Monferrato Alessandria
Italy Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Cremona
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Azienda Ospedaliera Universitaria Policlinico Tor Vergata Rome Roma
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Roma
Poland Szpitale Pomorskie spólka z ograniczona odpowiedzialnoscia Gdynia
Poland Szpital Specjalistyczny im. L.Rydygiera w Krakowie Krakow
Poland Mrukmed Lekarz Beata Madej Mruk i Partner Spólka Partnerska Oddzial nr 1 w Rzeszowie Rzeszów
Poland Centrum Medyczne Pratia Poznan Skórzewo
Poland Centrum Zdrowia MDM Warszawa
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain ICO l'Hospitalet - Hospital Duran i Reynals Barcelona
Spain Hospital Universitari Arnau de Vilanova Lleida
Spain Hospital Universitario Lucus Augsti Lugo
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario HM Madrid Sanchinarro Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
Ukraine CI Cherkasy Regional Oncological Dispensary of CRC Cherkasy
Ukraine Dnipropetrovsk City Multispecialty Clinical Hospital #4 Dnipro
Ukraine MI Regional Clinical Oncologycal Dispensary Dnipro
Ukraine Limited Liability Company "Medical Center named by Academician Yuriy Prokopovich Spizhenko" Kapitanivka
Ukraine CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC Kharkiv
Ukraine Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU Kharkiv
Ukraine Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus Kropyvnytskyi
Ukraine CI Kryvyi Rih Oncological Dispensary of DRC Kryvyi Rih
Ukraine Medical Center Asklepion LLC Kyiv
Ukraine Medical Center of Limited Liability Company Medical Center Concilium Medical Kyiv
Ukraine Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council Lutsk
Ukraine Communal Institution Odesa Regional Clinical Hospital; Department of Surgery Odesa
Ukraine University Hospital of Sumy State University Sumy
Ukraine CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU Uzhgorod
Ukraine Medical center "Oncolife" LLC Zaporizhzhia
United Kingdom Velindre Cancer Centre Cardiff South Glamorgan
United Kingdom Barts Hospital London Greater London
United Kingdom Royal Free Hospital London Greater London
United Kingdom The Christie Manchester Greater Manchester
United States Illinois Cancer Specialists Arlington Heights Illinois
United States Northside Hospital - Georgia Cancer Specialists Atlanta Georgia
United States Beverly Hills Cancer Center Beverly Hills California
United States Boston Medical Center Boston Massachusetts
United States UT Southwestern Medical Center Dallas Texas
United States Inova Schar Cancer Institute Fairfax Virginia
United States Florida Cancer Specialists (South Region) Fort Myers Florida
United States Florida Cancer Specialists NORTH Fort Myers Florida
United States Gettysburg Cancer Center Gettysburg Pennsylvania
United States Millennium Oncology Kingswood Texas
United States Comp. Cancer Centers of Nevada Las Vegas Nevada
United States Keck Medical Center of USC Pasadena Los Angeles California
United States Tennessee Oncology Nashville Tennessee
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Mid-Florida Hematology & Oncology Centers, P.A. Orange City Florida
United States Oregon Health & Science University Portland Oregon
United States Onc and Hem Assoc of SW VA Roanoke Virginia
United States Mayo Clinic - Rochester Rochester Minnesota
United States Florida Cancer Specialists Saint Petersburg Florida
United States Florida Cancer Specialists - Panhandle Tallahassee Florida
United States AZ Oncology Associates - HOPE Tucson Arizona
United States Georgetown University - Lombardi Comprehensive Cancer Center Washington District of Columbia
United States The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute Whittier California
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
G1 Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  China,  Hungary,  Italy,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myelopreservation To assess the effects of trilaciclib on the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by duration of severe [Grade 4] neutropenia [DSN] in Cycle 1 and occurrence of severe neutropenia [SN] during Induction Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Secondary Quality of Life/ Effects on Chemotherapy-Induced Fatigue To assess the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC, as measured by Time To First Confirmed Deterioration of Fatigue (TTCD-fatigue) during Induction, as measured by the FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue). Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Secondary Anti-tumor Efficacy To assess the effect of trilaciclib on Progression Free Survival (PFS) compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by Radiographic PFS (per RECIST 1.1) and OS From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first
Secondary Anti-tumor Efficacy To assess the effect of trilaciclib on Overall Survival (OS) compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by Radiographic PFS (per RECIST 1.1) and OS From date of randomization until date of death due to any cause
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