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    Summary
    EudraCT Number:2020-004930-39
    Sponsor's Protocol Code Number:G1T28-208
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2020-004930-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Triple-Negative Breast Cancer (TNBC) ( PRESERVE 2 )
    A.4.1Sponsor's protocol code numberG1T28-208
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorG1 Therapeutics, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportG1 Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG1 Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address700 Park Offices Dr. Suite 200
    B.5.3.2Town/ cityResearch Triangle Park
    B.5.3.3Post code27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number0001919 213 9835
    B.5.5Fax number0001919 741 5830
    B.5.6E-mailclinicalinfo@g1therapeutics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name COSELA
    D.2.1.1.2Name of the Marketing Authorisation holderG1 Therapeutics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrilaciclib
    D.3.2Product code G1T28
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrilaciclib dihydrochloride
    D.3.9.1CAS number 1977495-97-8
    D.3.9.2Current sponsor codeG1T28
    D.3.9.3Other descriptive nameG1T28 di-HCl, G1T28-1, CGB3RG-28-1, TRILA-IV, TRILA Di-HCl trilaciclib dihydrochloride, trilaciclib dihydrochloride dihydrate
    D.3.9.4EV Substance CodeSUB181989
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Advanced or Metastatic Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084066
    E.1.2Term Triple negative breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cohort 1: First-Line Population:
    To evaluate the effect of trilaciclib on OS compared with placebo

    NA since protocol 5.0 (Cohort 2: Second-line, Previously Treated with a PD-1/PD-L1 Inhibitor Population:
    To evaluate the effect of trilaciclib on OS compared with placebo) (for full wording see protocol)
    E.2.2Secondary objectives of the trial
    Both cohorts * To assess the effect of trilaciclib compared with placebo on:
    - OS in the PD-L1-positive or negative subgroup (Cohort 1 only)
    - progression-free survival
    - anti-tumor activity
    - quality of life related to fatigue
    - chemotherapy-induced myelosuppression related symptoms
    - myelopreservation effects
    - healthcare utilization
    - standard of care dosing
    - safety and tolerability

    *Cohort 2 is closed to enrollment as of 24 January 2022.
    (for full wording see protocol)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Female or male patients with evaluable locally advanced unresectable or metastatic TNBC
    2. Age ≥18 years
    3. Documentation of histologically or cytologically confirmed hormone (estrogen and progesterone) receptor negative tumor by immunohistochemistry (IHC) assessment (defined as <1% nuclei staining) and HER2-negative, non-overexpressing (by IHC [0 or 1+] OR in situ hybridization [ratio <2.0] OR average HER2 gene copy number of <4 signals/nucleus) on most recent biopsy per 2018 American Society of Clinical Oncology and the College of American Pathologists (ASCO CAP) criteria.
    4. Prior systemic therapies (Cohort 1 only):
    a. No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
    b. Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months. Note, prior PD-1/PD-L1 inhibitor in the (neo)adjuvant/ curative setting does not have time/interval restrictions. Washout of at least 14 days from prior PD-1/PDL1 inhibitor to the first dose of study drug is required.
    c. Only patients for whom treatment with a PD-1/PD-L1 inhibitor is not an option, either based on clinical eligibility or drug availability, will be enrolled in Cohort 1.
    5. Prior systemic therapies (Cohort 2 only, Cohort 2 is closed to enrollment as of 24 January 2022).
    a. Documentation of PD-L1 positive status
    b. Treated with a PD-1/PDL1 inhibitor for a minimum duration of 4 months in the locally advanced unresectable/metastatic setting and as the most recent therapy. Washout of at least 14 days from prior PD-1/PDL1 inhibitor to the first dose of study drug is required.
    6. Radiation therapy for metastatic disease is permitted. There is no required minimum washout period for these therapies. Patients should be recovered from the effects of radiation.
    7. Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor. If archival tissue is used, representative formalin-fixed paraffin embedded (FFPE) tumor specimens in paraffin blocks (75-micron) or at least 15 (5-micron) unstained slides are required.
    a. For Cohort 1 only, some of the tumor tissue noted above will be used for determination of tumor PD-L1 status using the Ventana SP-142 IVD assay which can be assay locally or centrally. Testing should be conducted on a recurrent/metastatic tumor; however, a primary lesion is acceptable. Documentation of PD-L1 status is acceptable for randomization if testing was done using the Ventana SP-142 IVD assay.
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    9. Adequate organ function as demonstrated by the following laboratory values:
    a. Hemoglobin ≥9.0 g/dL in the absence of RBC transfusion or ESA administration within 14 days prior to first dose of study drug
    b. Absolute neutrophil count (ANC) ≥1.5 × 10^9/L in the absence of G-CSF/ GM-CSF administration within 14 days prior to first dose of study drug
    c. Platelet count ≥100 × 10^9/L in the absence of platelet transfusion within 14 days prior to the first dose of study drug
    d. Estimated glomerular filtration rate ≥30 mL/minute/1.73 m2 (or calculated per institutional standards and local practice)
    e. Total bilirubin ≤1.5 × upper limit of normal (ULN) (<3 ULN if Gilbert’s disease)
    f. ALT and AST ≤2.5 × ULN (<5 ULN if documented liver metastases)
    10. Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to ≤Grade 1 (except alopecia)
    11. Predicted life expectancy of ≥3 months
    12. 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 17.3 for detailed instructions on methods of contraception requirements
    13. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
    14. Patients who consent to optional biopsy collection (at baseline and one on-treatment timepoint):
    Acceptable samples for both baseline and on-treatment timepoint include core needle biopsies (minimum three cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Tumor tissue should be from a locally recurrent or metastatic site and be of good quality based on total and viable tumor content. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. A minimum of three cores is acceptable.

    (see protocol for full information)
    E.4Principal exclusion criteria
    A patient will not be eligible for participation in this study if any of the following criteria apply:
    1. Prior treatment with gemcitabine in any setting.
    2. Prior treatment with carboplatin in the locally advanced unresectable/metastatic setting. Prior carboplatin in the (neo)adjuvant/curative setting is permitted as long as it was completed ≥ 6 months prior to the first metastatic recurrence
    3. Malignancies other than TNBC within 3 years prior to randomization: Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death <5% at 5 years as determined by the investigator) are eligible provided they meet all of the following criteria:
    a. Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent)
    b. No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers
    4. Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids. Patient must be off steroids administered for brain metastases for at least 14 days prior to the first dose of study drugs. No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to first dose of study drugs
    5. Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs
    6. Receipt of any investigational medication within 30 days, or at least 5 half-lives, whichever is greater, prior to the first dose of study drugs
    7. QTcF interval >480 msec at Screening. For patients with ventricular pacemakers, QTcF >500 msec
    8. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
    9. Known history of stroke or cerebrovascular accident within 6 months prior to first dose of study drugs
    10. Known serious active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
    11. Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
    12. Pregnant or lactating women
    13. Prior hematopoietic stem cell or bone marrow transplantation
    14. 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
    15. Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to first dose of study drugs, or anticipation of the need for major surgical procedure during the course of the study
    16. Receipt of a live, attenuated vaccine within 30 days prior to the first dose of study drugs or anticipation that such a live, attenuated vaccine will be required during the study treatment period
    E.5 End points
    E.5.1Primary end point(s)
    Cohort 1:
    - OS in the ITT population defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases).

    Cohort 2:
    - OS in the ITT population defined as time from randomization to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases).
    NOTE: The objectives, endpoints and planned analyses in Cohort 2 as of protocol v.5.0 are no longer applicable, and data from Cohort 2 will be summarized as appropriate. Cohort 2 is closed to enrollment as of 24 January 2022.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1: randomization to up to 39 months
    Cohort 2: randomization to up to 28 months

    NOTE: The objectives, endpoints and planned analyses in Cohort 2 as of protocol v.5.0 are no longer applicable, and data from Cohort 2 will be summarized as appropriate. Cohort 2 is closed to enrollment as of 24 January 2022.
    E.5.2Secondary end point(s)
    both Cohorts:
    • OS in PD-L1-positive subgroup (cohort 1 only)
    • OS in PD-L1-negative subgroup (cohort 1 only)
    • PFS in ITT population using RECIST v1.1, defined as time from randomization to disease progression or death due to any cause, whichever occurs first; for patients without disease progression or death, PFS will be calculated per censoring rules.
    • ORR, as defined as percentage of patients with confirmed CR and PR per RECIST v1.1
    • CBR, as defined as percentage of patients with confirmed CR, PR, and SD lasting 24 weeks or longer, as per RECIST v1.1
    • Duration of objective response per RECIST v1.1
    • Time to first confirmed deterioration of fatigue (TTCD-fatigue), as measured by the FACIT-F.
    • Change from baseline and/or time to deterioration in:
    a. FACT-G domain scores (physical, social/family, emotional, and functional well-being)
    b. FACT-An: Anemia
    c. EQ-5D-5L
    • Percent of patients reporting deterioration and improvement using:
    a. PGIC fatigue item
    b. PGIS fatigue item
    • Occurrence and severity of AEs by NCI CTCAE v5
    • Trilaciclib AESIs
    • Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters
    • Grade 3 or 4 abnormalities in serum chemistry laboratory parameters
    • Trilaciclib infusion interruptions
    • Chemotherapy dose modifications
    • Relative dose intensity for gemcitabine and carboplatin

    Secondary Objectives: to evaluate the myelopreservation effect of trilaciclib compared with placebo
    • Duration of severe (Grade 4) neutropenia in Cycle 1
    • Occurrence of severe (Grade 4) neutropenia
    • Occurrence of febrile neutropenia AEs
    • Occurrence of G-CSF administration
    • Occurrence of Grade 3 or 4 decreased hemoglobin laboratory values
    • RBC transfusions on or after Week 5 (occurrence and number of transfusions)
    • Occurrence of ESA administration
    • Occurrence of Grade 3 or 4 decreased platelet count laboratory values
    • Platelet transfusions (occurrence and number of transfusions)
    • Occurrence and number of hospitalizations due to chemotherapy-induced myelosuppression
    • All-cause dose reductions (occurrence and number of reductions)
    • All-cause cycle delays (occurrence and number of delays)

    NOTE: The objectives, endpoints and planned analyses in Cohort 2 as of protocol v.5.0 are no longer applicable, and data from Cohort 2 will be summarized as appropriate. Cohort 2 is closed to enrollment as of 24 January 2022.
    E.5.2.1Timepoint(s) of evaluation of this end point
    thorough the study as per the schedule of assessments in the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarkers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Georgia
    Moldova, Republic of
    Russian Federation
    Ukraine
    Serbia
    Bulgaria
    France
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is event driven. That is, each cohort will continue until the targeted number of deaths is observed. There is an interim analysis for OS in Cohort 1. If the interim results demonstrate a statistically significant effect of trilaciclib over placebo for OS based on pre-specified criterion, Cohort 1 will be stopped early due to success. In that event, Cohort 2 will continue until the targeted number of deaths is observed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 170
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of study treatment on the study, patients will receive treatment as determined by their healthcare provider.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-04-24
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