Colorectal Cancer Metastatic Clinical Trial
— PRESERVE1Official title:
PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
Verified date | April 2023 |
Source | G1 Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
G1 Therapeutics, Inc. |
United States, China, Hungary, Italy, Poland, Spain, Ukraine, United Kingdom,
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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