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

Primary Purpose

Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trilaciclib
Placebo
Sponsored by
G1 Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Oncology Associates - HOPE
  • Beverly Hills Cancer Center
  • Keck Medical Center of USC Pasadena
  • The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute
  • Georgetown University - Lombardi Comprehensive Cancer Center
  • Florida Cancer Specialists (South Region)
  • Florida Cancer Specialists NORTH
  • Mid-Florida Hematology & Oncology Centers, P.A.
  • Florida Cancer Specialists
  • Florida Cancer Specialists - Panhandle
  • Northside Hospital - Georgia Cancer Specialists
  • Illinois Cancer Specialists
  • Boston Medical Center
  • University of Massachusetts Memorial Medical Center
  • Mayo Clinic - Rochester
  • Comp. Cancer Centers of Nevada
  • University of Oklahoma Health Sciences Center
  • Oregon Health & Science University
  • Gettysburg Cancer Center
  • Tennessee Oncology
  • UT Southwestern Medical Center
  • Millennium Oncology
  • Inova Schar Cancer Institute
  • Onc and Hem Assoc of SW VA
  • Henan Cancer Hospital
  • Wuhan Union Hospital
  • Jilin Provincial Tumor Hospital
  • The First Affiliated Hospital of Zhejiang University
  • Zhejiang Cancer Hospital
  • The Affiliated Tumor Hospital of Harbin Medical University
  • Jinan Central hospital
  • Zhongshan Hospital Fudan University
  • Xuzhou Central hospital
  • First Affiliated Hospital of Zhengzhou University
  • Orszagos Onkologiai Intezet
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Bacs-Kiskun Megyei Oktatokorhaz
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato)
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria Careggi
  • Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
  • Szpital Specjalistyczny im. L.Rydygiera w Krakowie
  • Mrukmed Lekarz Beata Madej Mruk i Partner Spółka Partnerska Oddział nr 1 w Rzeszowie
  • Centrum Medyczne Pratia Poznan
  • Centrum Zdrowia MDM
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • ICO l'Hospitalet - Hospital Duran i Reynals
  • Hospital Universitari Arnau de Vilanova
  • Hospital Universitario Lucus Augsti
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario HM Madrid Sanchinarro
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitario Virgen Macarena
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitario Miguel Servet
  • CI Cherkasy Regional Oncological Dispensary of CRC
  • MI Regional Clinical Oncologycal Dispensary
  • Dnipropetrovsk City Multispecialty Clinical Hospital #4
  • Limited Liability Company "Medical Center named by Academician Yuriy Prokopovich Spizhenko"
  • CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
  • Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU
  • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
  • CI Kryvyi Rih Oncological Dispensary of DRC
  • Medical Center Asklepion LLC
  • Medical Center of Limited Liability Company Medical Center Concilium Medical
  • Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
  • Communal Institution Odesa Regional Clinical Hospital; Department of Surgery
  • University Hospital of Sumy State University
  • CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU
  • Medical center "Oncolife" LLC
  • Barts Hospital
  • Royal Free Hospital
  • The Christie
  • Velindre Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

trilaciclib + FOLFOXIRI/bevacizumab

placebo + FOLFOXIRI/bevacizumab

Arm Description

During Induction the following study drugs are administered on Day 1: Irinotecan- IV Oxaliplatin - IV Leucovorin- IV Fluorouracil - continuous infusion (CI) over 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. Trilaciclib will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.

The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
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

Full Information

First Posted
October 20, 2020
Last Updated
April 5, 2023
Sponsor
G1 Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04607668
Brief Title
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
Acronym
PRESERVE1
Official Title
PRESERVE 1: A Phase 3 Randomized, Double-blind Trial of Trilaciclib Versus Placebo in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Despite achieving co-primary endpoints & other secondary measures of myeloprotection & tolerability, early anti-tumor efficacy data favor patients receiving placebo. Given the low likelihood of achieving PFS & OS endpoints, G1 decided to discontinue
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
February 13, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G1 Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-Blinded Trial
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trilaciclib + FOLFOXIRI/bevacizumab
Arm Type
Experimental
Arm Description
During Induction the following study drugs are administered on Day 1: Irinotecan- IV Oxaliplatin - IV Leucovorin- IV Fluorouracil - continuous infusion (CI) over 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. Trilaciclib will be administered prior to infusional-5FU/leucovorin/bevacizumab at the same dose and schedule used during Induction.
Arm Title
placebo + FOLFOXIRI/bevacizumab
Arm Type
Placebo Comparator
Arm Description
The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib
Intervention Type
Drug
Intervention Name(s)
Trilaciclib
Other Intervention Name(s)
G1T28, CDK 4/6 inhibitor
Intervention Description
Trilaciclib or placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
dextrose 5% in water or normal saline (sodium chloride solution 0.9%)
Primary Outcome Measure Information:
Title
Myelopreservation
Description
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
Time Frame
Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Secondary Outcome Measure Information:
Title
Quality of Life/ Effects on Chemotherapy-Induced Fatigue
Description
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).
Time Frame
Through Induction Period- on average 24 weeks (up to 12 cycles) of FOLFOXIRI/bevacizumab
Title
Anti-tumor Efficacy
Description
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
Time Frame
From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first
Title
Anti-tumor Efficacy
Description
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
Time Frame
From date of randomization until date of death due to any cause

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Contact
Organizational Affiliation
G1 Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AZ Oncology Associates - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Keck Medical Center of USC Pasadena
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Oncology Institute of Hope & Innovation\ Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Georgetown University - Lombardi Comprehensive Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists (South Region)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Florida Cancer Specialists NORTH
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Mid-Florida Hematology & Oncology Centers, P.A.
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Northside Hospital - Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Comp. Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Millennium Oncology
City
Kingswood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Inova Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Onc and Hem Assoc of SW VA
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Henan Cancer Hospital
City
Zijingshan
State/Province
Henan
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jilin Provincial Tumor Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The Affiliated Tumor Hospital of Harbin Medical University
City
Heilongjiang
Country
China
Facility Name
Jinan Central hospital
City
Shandong
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Xuzhou Central hospital
City
Xuzhou
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Oktatokorhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
ASL Regionale Piemonte - Ospedale Santo Spirito Casale Monferrato (Ospedale di Casale Monferrato)
City
Casale Monferrato
State/Province
Alessandria
ZIP/Postal Code
15033
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Szpital Specjalistyczny im. L.Rydygiera w Krakowie
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Mrukmed Lekarz Beata Madej Mruk i Partner Spółka Partnerska Oddział nr 1 w Rzeszowie
City
Rzeszów
ZIP/Postal Code
35-922
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario Lucus Augsti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
CI Cherkasy Regional Oncological Dispensary of CRC
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
MI Regional Clinical Oncologycal Dispensary
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Dnipropetrovsk City Multispecialty Clinical Hospital #4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Limited Liability Company "Medical Center named by Academician Yuriy Prokopovich Spizhenko"
City
Kapitanivka
ZIP/Postal Code
8112
Country
Ukraine
Facility Name
CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
City
Kropyvnytskyi
Country
Ukraine
Facility Name
CI Kryvyi Rih Oncological Dispensary of DRC
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Medical Center Asklepion LLC
City
Kyiv
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Center Concilium Medical
City
Kyiv
Country
Ukraine
Facility Name
Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Communal Institution Odesa Regional Clinical Hospital; Department of Surgery
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
University Hospital of Sumy State University
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU
City
Uzhgorod
Country
Ukraine
Facility Name
Medical center "Oncolife" LLC
City
Zaporizhzhia
ZIP/Postal Code
69059
Country
Ukraine
Facility Name
Barts Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Christie
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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