Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): (PRESERVE1)

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer Metastatic; Chemotherapeutic Toxicity; Myelosuppression-Adult
• Intervention / Treatment: Drug: Trilaciclib; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Heilongjiang, China
    • The Affiliated Tumor Hospital of Harbin Medical University
  • Shandong, China
    • Jinan Central Hospital
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University
  • Xuzhou, China
    • Xuzhou Central Hospital
  • Zhengzhou, China
    • First Affiliated Hospital of Zhengzhou University
  • Henan
    • Zijingshan, Henan, China
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Union Hospital
  • Jilin
    • Changchun, Jilin, China
      • Jilin Provincial Tumor Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Kecskemet, Hungary, 6000
    • Bacs-Kiskun Megyei Oktatokorhaz
  • Nyiregyhaza, Hungary, 4400
    • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
• Italy
  • Cremona, Italy, 26100
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Firenze, Italy, 50141
    • Azienda Ospedaliera Universitaria Careggi
  • Alessandria
    • Casale Monferrato, Alessandria, Italy, 15033
      • ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato)
  • Roma
    • Rome, Roma, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Poland
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
  • Krakow, Poland, 31-637
    • Szpital Specjalistyczny im. L.Rydygiera w Krakowie
  • Rzeszów, Poland, 35-922
    • Mrukmed Lekarz Beata Madej Mruk i Partner Spółka Partnerska Oddział nr 1 w Rzeszowie
  • Skórzewo, Poland, 60-185
    • Centrum Medyczne Pratia Poznań
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08907
    • ICO l'Hospitalet - Hospital Duran i Reynals
  • Lleida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augsti
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario la Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Madrid, Spain, 28050
    • Hospital Universitario HM Madrid Sanchinarro
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Ukraine
  • Cherkasy, Ukraine, 18009
    • CI Cherkasy Regional Oncological Dispensary of CRC
  • Dnipro, Ukraine, 49100
    • MI Regional Clinical Oncologycal Dispensary
  • Dnipro, Ukraine, 49102
    • Dnipropetrovsk City Multispecialty Clinical Hospital #4
  • Kapitanivka, Ukraine, 8112
    • Limited Liability Company "Medical Center named by Academician Yuriy Prokopovich Spizhenko"
  • Kharkiv, Ukraine, 61037
    • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Kharkiv, Ukraine, 61070
    • Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU
  • Kropyvnytskyi, Ukraine
    • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
  • Kryvyi Rih, Ukraine, 50048
    • CI Kryvyi Rih Oncological Dispensary of DRC
  • Kyiv, Ukraine
    • Medical Center Asklepion Llc
  • Kyiv, Ukraine
    • Medical Center of Limited Liability Company Medical Center Concilium Medical
  • Lutsk, Ukraine, 43018
    • Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
  • Odesa, Ukraine, 65025
    • Communal Institution Odesa Regional Clinical Hospital; Department of Surgery
  • Sumy, Ukraine, 40022
    • University Hospital of Sumy State University
  • Uzhgorod, Ukraine
    • CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU
  • Zaporizhzhia, Ukraine, 69059
    • Medical center "Oncolife" LLC
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, NW3 2QG
      • Royal Free Hospital
    • London, Greater London, United Kingdom, EC1A 7BE
      • Barts Hospital
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
      • Velindre Cancer Centre
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • AZ Oncology Associates - HOPE
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC Pasadena
    • Whittier, California, United States, 90603
      • The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University - Lombardi Comprehensive Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists (South Region)
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists North
    • Orange City, Florida, United States, 32763
      • Mid-Florida Hematology & Oncology Centers, P.A.
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists - Panhandle
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital - Georgia Cancer Specialists
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comp. Cancer Centers of Nevada
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Gettysburg Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Kingswood, Texas, United States, 77339
      • Millennium Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
    • Roanoke, Virginia, United States, 24014
      • Onc and Hem Assoc of SW VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 > 14.
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 (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.
3. Unresectable and measurable or metastatic colorectal cancer 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 (tissue requirements are provided in the associated laboratory manual).
6. Hemoglobin ≥ 9.0 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of trilaciclib/placebo
7. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9 /L
8. Platelet count ≥ 100 × 10^9 /L
9. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73m^2
10. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
11. 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
12. Resolution of nonhematologic toxicities from prior therapy or surgical procedures to ≤ Grade 1 or baseline (except alopecia)
13. 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
14. 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.
15. 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.

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 (i.e., patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of trilaciclib/placebo).
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. Uncontrolled hypertension (blood pressure ≥ 150/90mm Hg)
10. 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])
11. Serious, non-healing wound, ulcer, or bone fracture
12. 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.
13. Known serious active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.)
14. Known Gilbert's Syndrome or homozygous for the UGT1A1*28 allele. UGT1A1 genotyping is not required for this study.
15. Chronic inflammatory bowel disease and/or active intestinal obstruction. Patients should not be treated until the intestinal obstruction has resolved.
16. Previous history of significant/severe hemorrhage, within 1 month before randomization. History of previous abdominal fistula or gastrointestinal perforation within 6 months before randomization
17. Known history of bleeding diathesis or coagulopathy
18. 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.
19. 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.
20. Patients with ongoing or anticipated treatment with sorivudine or its chemically related analogues, such as brivudine.
21. Chronic, daily treatment with high-dose aspirin (> 325 mg/day)
22. Prior allogeneic or autologous hematopoietic stem cell or bone marrow transplantation
23. Receipt of any live attenuated vaccines within 4 weeks prior to first dose of study treatment
24. Known hypersensitivity to any of the drugs used in this study
25. Pregnant or lactating women
26. Legal incapacity or limited legal capacity
27. 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
28. Any contraindications to the administration of FOLFOXIRI and bevacizumab at the discretion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trilaciclib + FOLFOXIRI/bevacizumab; During 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.	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.; Other Names: G1T28; CDK 4/6 inhibitor
Placebo Comparator: placebo + FOLFOXIRI/bevacizumab; The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Cycles 1 to 4 (14-day cycles up to 56 days)
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)	Induction Period, cycles 1-12 (14-day cycles up to 168 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	Up to 52 months
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)	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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.	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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.	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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.	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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.	Through Induction Period - on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
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.	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
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.	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
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.	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
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.	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

Collaborators and Investigators

• Sponsor: G1 Therapeutics, Inc.
• Investigators: Study Director: Clinical Contact, G1 Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: bevacizumab; Colorectal Cancer; colon; rectum; FOLFOXIRI; CDK 4/6 inhibitor; mCRC; myelosuppression; trilaciclib; cyclin-dependent kinase 4/6 inhibitor; chemotherapy-induced myelosuppression; chemotherapy-induced neutropenia; chemotherapy-induced anemia; myelopreservation; Preserve; PRESERVE 1
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: G1T28-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No