Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
NCT ID: NCT02499770
Last Updated: 2020-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
122 participants
INTERVENTIONAL
2015-06-26
2019-02-22
Brief Summary
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The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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trilaciclib + carboplatin/etoposide
All patients in part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy- carboplatin and etoposide. Patients will have PK assessments completed on days 1 and 3 in cycle 1 only. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
Carboplatin
Trilaciclib
Etoposide
trilaciclib/placebo + carboplatin/etoposide
All patients enrolled in part 2 will be randomized to receive either trilaciclib (G1T28) or placebo administered prior to standard chemotherapy- carboplatin and etoposide. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
Carboplatin
Placebo
Trilaciclib
Etoposide
Interventions
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Carboplatin
Placebo
Trilaciclib
Etoposide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
* At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
* Adequate organ function
Exclusion Criteria
* Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
* Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
* Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
* Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
* Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
* Receipt of any investigational medication within 4 weeks prior to enrollment
18 Years
ALL
No
Sponsors
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G1 Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Contact
Role: STUDY_DIRECTOR
G1 Therapeutics, Inc.
Locations
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Genesis Cancer Center
Hot Springs, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Memorial Hospital - Univ. of Colorado Health
Colorado Springs, Colorado, United States
University of Colorado Health, Oncology Clinical Research Northern Region
Fort Collins, Colorado, United States
Boca Raton Regional Hospital - Lynn Cancer Institute
Boca Raton, Florida, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Florida Cancer Specialists - North
Tavares, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
University Cancer and Blood Center, LLC
Athens, Georgia, United States
Emory University
Atlanta, Georgia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Roswell Park
Buffalo, New York, United States
UNC - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Oklahoma University - Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
Gibbs Cancer Center
Spartanburg, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Hanna Cancer Associates - University of Tennessee
Knoxville, Tennessee, United States
Texas Oncology
Tyler, Texas, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
CHU de Rennes Hopital Pontchaillou
Rennes, , France
ARENSIA Exploratory Medicine LLC
Tbilisi, , Georgia
Veszprem Megyei Tudogyogyintezet
Farkasgyepű, Veszprém megye, Hungary
Orszagos Koranyi Tbc es Pulmonologiai Intezet, XI. Tudobelosztaly
Budapest, , Hungary
Hetenyi Geza Korhaz
Szolnok, , Hungary
ARENSIA Exploratory Medicine Phase I Unit, The Institute of Oncology
Chisinau, , Moldova
Samodzielny Publiczny ZespAA GruAicy i ChorAb PA¿uc
Olsztyn, , Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera
Torun, , Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, , Poland
Hospital Regional Universitario HRU Carlos Haya Malaga
Málaga, Andalusia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Consorcio Hospitalario Provincial
Castillón, , Spain
Hgu Gregorio Maranon
Madrid, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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References
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Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.
Ferrarotto R, Anderson I, Medgyasszay B, Garcia-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csoszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.
Li C, Hart L, Owonikoko TK, Aljumaily R, Rocha Lima CM, Conkling PR, Webb RT, Jotte RM, Schuster S, Edenfield WJ, Smith DA, Sale M, Roberts PJ, Malik RK, Sorrentino JA. Trilaciclib dose selection: an integrated pharmacokinetic and pharmacodynamic analysis of preclinical data and Phase Ib/IIa studies in patients with extensive-stage small cell lung cancer. Cancer Chemother Pharmacol. 2021 May;87(5):689-700. doi: 10.1007/s00280-021-04239-9. Epub 2021 Feb 17.
Lai AY, Sorrentino JA, Dragnev KH, Weiss JM, Owonikoko TK, Rytlewski JA, Hood J, Yang Z, Malik RK, Strum JC, Roberts PJ. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020 Oct;8(2):e000847. doi: 10.1136/jitc-2020-000847.
Weiss JM, Csoszi T, Maglakelidze M, Hoyer RJ, Beck JT, Domine Gomez M, Lowczak A, Aljumaily R, Rocha Lima CM, Boccia RV, Hanna W, Nikolinakos P, Chiu VK, Owonikoko TK, Schuster SR, Hussein MA, Richards DA, Sawrycki P, Bulat I, Hamm JT, Hart LL, Adler S, Antal JM, Lai AY, Sorrentino JA, Yang Z, Malik RK, Morris SR, Roberts PJ, Dragnev KH; G1T28-02 Study Group. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019 Oct 1;30(10):1613-1621. doi: 10.1093/annonc/mdz278.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001583-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
G1T28-02
Identifier Type: -
Identifier Source: org_study_id
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