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AzTrials

Colorectal Cancer MetastaticPhase 3PRESERVE1NCT04607668

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

A Phase 3 study testing Trilaciclib in people with Colorectal Cancer Metastatic and Myelosuppression-Adult, run by G1 Therapeutics, Inc. at 82 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Trilaciclib
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
326 participants
Where
82 sitesin 8 countries
Study dates
6 Jan 2021to 31 Mar 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 > 14.
  • 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 (wild type or mutant) are eligible. If historical pMMR/MSS and/or BRAF V600E mutational status are not known, a tumor specimen (archival or fresh biopsy) must be sent for testing and results must be available at the time of randomization in interactive web response system (IWRS). If testing cannot be completed using a standard clinical assay performed institutionally/locally, the tumor specimen may be sent to the Sponsor's designated central laboratory for analysis; only historical KRAS mutational status will be collected (ie, no testing required prior to study entry). Note: Any sample sent for MSS/BRAF analysis will be in addition to that required per Inclusion Criterion 5.
  • Unresectable and measurable or metastatic colorectal cancer 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 (tissue requirements are provided in the associated laboratory manual).
  • Hemoglobin ≥ 9.0 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of trilaciclib/placebo
Show all 15Show fewer
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L
  • Platelet count ≥ 100 × 10^9 /L
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73m^2
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
  • AST, ALT, and alkaline phosphatase ≤ 3 × ULN for patients without liver or bone metastases; AST, ALT and alkaline phosphatase ≤ 5 × ULN in the presence of liver metastases; AST and ALT ≤ 3 x ULN and alkaline phosphatase ≤ 5 × ULN in the presence of bone metastases
  • Resolution of nonhematologic toxicities from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia)
  • Urine dipstick protein < 2+. If ≥ 2+ at Screening, then a 24-hour urine collection must be done to demonstrate ≤ 1 g of protein/24 hours
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Please see Section 17.4 for detailed instructions on methods of contraception requirements.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • 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 (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo).
  • 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
Show all 28Show fewer
  • Symptomatic peripheral neuropathy
  • History of interstitial lung disease (ILD)
  • Uncontrolled hypertension (blood pressure ≥ 150/90mm Hg)
  • Clinically significant (i.e., active) cardiovascular disease at the time of signing the informed consent; for example cerebrovascular accidents (≤ 6 months before the first dose of trilaciclib/placebo), myocardial infarction (≤ 6 months before the first dose of trilaciclib/placebo), unstable angina, serious cardiac arrhythmia requiring medication, or uncontrolled symptomatic congestive heart failure [Class II or higher as defined by the New York Heart Association [NYHA] functional classification system])
  • Serious, non-healing wound, ulcer, or bone fracture
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
  • Known serious active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.)
  • Known Gilbert's Syndrome or homozygous for the UGT1A1*28 allele. UGT1A1 genotyping is not required for this study.
  • Chronic inflammatory bowel disease and/or active intestinal obstruction. Patients should not be treated until the intestinal obstruction has resolved.
  • Previous history of significant/severe hemorrhage, within 1 month before randomization. History of previous abdominal fistula or gastrointestinal perforation within 6 months before randomization
  • Known history of bleeding diathesis or coagulopathy
  • INR > 1.5 within 14 days prior to starting study treatment. EXEMPTION: patients on full anticoagulation must have an in-range INR (usually between 2 to 3) if INR is used for monitoring. Any anticoagulation therapy must be at stable dosing prior to enrollment.
  • Ongoing or anticipated treatment with potent cytochrome inhibitors CYP450 3A4 (such as ketoconazole) or inducers (such as rifampicin, carbamazepine, phenobarbital, phenytoin or St. John's wort). Irinotecan should not be delivered concurrently.
  • Patients with ongoing or anticipated treatment with sorivudine or its chemically related analogues, such as brivudine.
  • Chronic, daily treatment with high-dose aspirin (> 325 mg/day)
  • Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation
  • Receipt of any live attenuated vaccines within 4 weeks prior to first dose of study treatment
  • Known hypersensitivity to any of the drugs used in this study
  • Pregnant or lactating women
  • Legal incapacity or limited legal capacity
  • Other uncontrolled serious chronic disease or psychiatric condition that in the Investigator's opinion could affect patient safety, compliance, or follow-up in the protocol
  • Any contraindications to the administration of FOLFOXIRI and bevacizumab at the discretion of the investigator.

Trial locations and contacts

82 sites in 8 countries.

82 sites in 8 countries

United States24 sites

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Northside Hospital - Georgia Cancer Specialists

    Atlanta, Georgia, 30342

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Florida Cancer Specialists (South Region)

    Fort Myers, Florida, 33916

  • Florida Cancer Specialists NORTH

    Fort Myers, Florida, 33916

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Millennium Oncology

    Kingswood, Texas, 77339

  • Comp. Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Keck Medical Center of USC Pasadena

    Los Angeles, California, 90033

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mid-Florida Hematology & Oncology Centers, P.A.

    Orange City, Florida, 32763

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Onc and Hem Assoc of SW VA

    Roanoke, Virginia, 24014

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists - Panhandle

    Tallahassee, Florida, 32308

  • AZ Oncology Associates - HOPE

    Tucson, Arizona, 85711

  • Georgetown University - Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

  • The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute

    Whittier, California, 90603

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Spain15 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08907

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario Lucus Augsti

    Lugo, 27003

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Ukraine15 sites

  • CI Cherkasy Regional Oncological Dispensary of CRC

    Cherkasy, 18009

  • MI Regional Clinical Oncologycal Dispensary

    Dnipro, 49100

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4

    Dnipro, 49102

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

    Kapitanivka, 8112

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

    Kharkiv, 61037

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

    Kharkiv, 61070

  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

    Kropyvnytskyi

  • CI Kryvyi Rih Oncological Dispensary of DRC

    Kryvyi Rih, 50048

  • Medical Center Asklepion LLC

    Kyiv

  • Medical Center of Limited Liability Company Medical Center Concilium Medical

    Kyiv

  • Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council

    Lutsk, 43018

  • Communal Institution Odesa Regional Clinical Hospital; Department of Surgery

    Odesa, 65025

  • University Hospital of Sumy State University

    Sumy, 40022

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

    Uzhhorod

  • Medical center "Oncolife" LLC

    Zaporizhzhya, 69059

Other trials in Ukraine

China10 sites

  • Jilin Provincial Tumor Hospital

    Changchun, Jilin

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • The Affiliated Tumor Hospital of Harbin Medical University

    Heilongjiang

  • Jinan Central hospital

    Shandong

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Wuhan Union Hospital

    Wuhan, Hubei

  • Xuzhou Central hospital

    Xuzhou

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Henan Cancer Hospital

    Zijingshan, Henan

Other trials in China

Italy5 sites

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

    Casale Monferrato, Alessandria, 15033

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Cremona, 26100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50141

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Roma, 00168

Other trials in Italy

Poland5 sites

  • Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

    Gdynia, 81-519

  • Szpital Specjalistyczny im. L.Rydygiera w Krakowie

    Krakow, 31-637

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

    Rzeszów, 35-922

  • Centrum Medyczne Pratia Poznan

    Skórzewo, 60-185

  • Centrum Zdrowia MDM

    Warsaw, 00-635

Other trials in Poland

Hungary4 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

    Gyula, 5700

  • Bacs-Kiskun Megyei Oktatokorhaz

    Kecskemét, 6000

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

Other trials in Hungary

United Kingdom4 sites

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL

  • Barts Hospital

    London, Greater London, EC1A 7BE

  • Royal Free Hospital

    London, Greater London, NW3 2QG

  • The Christie

    Manchester, Greater Manchester, M20 4BX

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

Patients were 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 continued in Maintenance, where they received 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 continued 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 occurred consecutively without interruption, except when necessary to manage toxicities or for administrative reasons.

Being tested
Trilaciclib, Placebo
Keywords
Colorectal Cancer, mCRC, colon, chemotherapy-induced myelosuppression, chemotherapy-induced neutropenia, chemotherapy-induced anemia, CDK 4/6 inhibitor, trilaciclib, FOLFOXIRI, bevacizumab, myelosuppression, cyclin-dependent kinase 4/6 inhibitor, myelopreservation, rectum, Preserve, PRESERVE 1
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrilaciclibDrug

    Also called G1T28, CDK 4/6 inhibitor

    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.

  • PlaceboDrug

    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.

Study groups in NCT04607668
Study groupRoleWhat they receive
trilaciclib + FOLFOXIRI/bevacizumabExperimentalDuring Induction the following study drugs are administered on Day 1: Irinotecan - IV, Oxaliplatin - IV, Leucovorin- IV, Fluorouracil - continuous infusion (CI) over 46 to 48 hours beginning on Day 1, Bevacizumab - IV Following completion of Induction, patients will continue in Maintenance, where they will continue to receive trilaciclib per randomization allocation at study entry. Trilaciclib will be administered prior to infusional- 5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.
Receives: Drug: Trilaciclib
placebo + FOLFOXIRI/bevacizumabPlacebo comparatorThe subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Severe Neutropenia (DSN)

    The DSN was defined as the number of days for the first severe neutropenia (SN) event in Cycles 1, 2, 3, or 4 for participants who had at least one SN event in the first 4 cycles of Induction. It was calculated as the days from the date of the first absolute neutrophil count (ANC) value of < 0.5 × 10^9/L to the date of the first ANC value ≥ 0.5 × 10^9/L where no additional ANC values < 0.5 × 10^9/L were observed for the remainder of that cycle.

    Measured: Cycles 1 to 4 (14-day cycles up to 56 days)

  2. Occurrence of Severe Neutropenia (SN) During Induction

    Severe neutropenia was defined as the absolute neutrophil count (ANC) laboratory value that met the Common Terminology Criteria for Adverse vents (CTCAE) criteria for ≥ Grade 4 toxicity (ie, ANC < 0.5 × 10^9/L in SI Unit)

    Measured: Induction Period, cycles 1-12 (14-day cycles up to 168 days)

Secondary outcomes (13)

  1. Overall Survival (OS)

    Overall survival is defined as the time from the date of the first dose of study treatment to the date of death from any cause.

    Measured: Up to 52 months

  2. Additional Myelopreservation Measures

    To assess the effects of trilaciclib on additional measures of the neutrophil lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC as measured by the number of SN events, granulocyte-colony stimulating factor (G-CSF) administration and febrile neutropenia (FN) adverse events (AE)

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  3. Red Blood Cell Lineage

    To assess the effects of trilaciclib on the red blood cell (RBC) lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 decreased hemoglobin laboratory values, RBC transfusions on or after Week 5, and erythropoiesis-stimulating agents (ESA) administration

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  4. Platelet Lineage

    To assess the effects of trilaciclib on the platelet lineage compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCR by measure of Grade 3 or 4 decreased platelet count laboratory values and Platelet transfusions.

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  5. Multiple Lineage

    To assess the effects of trilaciclib on multiple lineages compared with placebo in patients receiving FOLFOXIRI/bevacizumab for pMMR/MSS mCRC by measure of Grade 3 or 4 hematologic lab values.

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  6. Standard of Care Dosing

    To assess the effects of trilaciclib on standard of care dosing compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of all-cause dose reductions or cycle delays and relative dose intensity for FOLFOXIRI/bevacizumab

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  7. Healthcare Utilization

    To assess the effects of trilaciclib on healthcare utilization compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of hospitalizations and antibiotic use.

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  8. Best Overall Response (BOR)

    Best overall response (BOR) will be determined using all visit responses prior to or on the date of (i) radiographic disease progression; (ii) withdrawal of consent to obtain scans; (iii) death; (iv) lost to follow-up; or (v) initiation of subsequent anti-cancer therapy other than the study drugs, whichever is earlier will be based on RECIST v1.1.

    Measured: Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  9. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference based on RECIST v1.1.

    Measured: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks

  10. Duration of Objective Response (DOR)

    DOR is the time between first objective response of CR or PR and the first date that progressive disease is objectively documented or death, whichever comes first.

    Measured: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks

  11. Progression Free Survival (PFS)

    PFS is defined as the time from the date of randomization until the date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first.

    Measured: Assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks

  12. 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).

    Measured: Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab

  13. Number of Participants With Reported Adverse Events to Measure Safety and Tolerability

    To assess the safety and tolerability of trilaciclib compared with placebo in patients receiving FOLFOXIRI/ bevacizumab for pMMR/MSS mCRC by measure of occurrence and severity of AEs by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, changes in laboratory parameters, vital signs and electrocardiogram (ECG) parameters, grade 3 or 4 abnormalities in chemistry laboratory parameters, and study treatment discontinuation due to AEs.

    Measured: Safety was assessed from the day of the first dose of the study drug, through 30 days after the last dose of the study drug, up to 115 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start6 Jan 2021
  3. Primary completion13 Feb 2023
  4. Study completion31 Mar 2023

Why it stopped: The Sponsor made the decision to terminate the study and complete the final analysis for available data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607668
Sponsor's protocol ID
G1T28-207
Acronym
PRESERVE1
Status last verified
Oct 2024
First submitted
20 Oct 2020
Last updated
26 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lenz HJ, Liu T, Chen EY, Horvath Z, Bondarenko I, Danielewicz I, Ghidini M, Garcia-Alfonso P, Jones R, Aapro M, Zhang Y, Wang J, Wang W, Adeleye J, Beelen A, Hubbard J. Trilaciclib prior to FOLFOXIRI/bevacizumab for patients with untreated metastatic colorectal cancer: phase 3 PRESERVE 1 trial. JNCI Cancer Spectr. 2025 Jan 3;9(1):pkae116. doi: 10.1093/jncics/pkae116.

    PubMed 39579142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trilaciclib in people with Colorectal Cancer Metastatic and Myelosuppression-Adult, run by G1 Therapeutics, Inc. at 82 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Spain, Ukraine, China, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Severe Neutropenia (DSN) (time frame: Cycles 1 to 4 (14-day cycles up to 56 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607668, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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