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Trial record 1 of 1 for:    NCT02978716
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Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

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ClinicalTrials.gov Identifier: NCT02978716
Recruitment Status : Active, not recruiting
First Posted : December 1, 2016
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
G1 Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE December 1, 2016
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE February 7, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Number of Treatment Related Adverse Event, including Abnormal Laboratory Events [ Time Frame: 18 months ]
All AEs, including clinical laboratory, vitals signs, physical examinations and ECGs will be analyzed in all patients receiving study drug from from the signing of the informed consent until 30 days after the last dose of study medication up to 18 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02978716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Tumor response based on RECIST, Version 1.1 [ Time Frame: 18 months ]
  • Progression free survival (PFS) [ Time Frame: 27 months ]
  • Overall survival (OS) [ Time Frame: 36 months ]
  • Hematologic parameters [ Time Frame: 18 months ]
    Number of patients with treatment related abnormal laboratory assessments. Laboratory toxicities will be assessed using NCI CTCAE, Version 4.03
  • Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Maximum Plasma Concentration (Cmax) [ Time Frame: 24 hours ]
    The observed peak plasma concentration determined from the plasma (Cmax)
  • Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Area under Curve - plasma concentration (AUC) [ Time Frame: 24 hours ]
    Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma: terminal half life (T1/2) [ Time Frame: 24 hours ]
    Plasma- terminal half life (T1/2)
  • Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma - Volume of distribution [ Time Frame: 24 hours ]
    Volume of distribution in the terminal elimination phase (Vz)
  • Incidence of chemotherapy dose reductions [ Time Frame: 18 months ]
  • Incidence of dose interruptions overall [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Tumor response based on RECIST, Version 1.1 [ Time Frame: 18 months ]
  • Progression free survival (PFS) [ Time Frame: 27 months ]
  • Overall survival (OS) [ Time Frame: 36 months ]
  • Hematologic parameters [ Time Frame: 18 months ]
    Number of patients with treatment related abnormal laboratory assessments. Laboratory toxicities will be assessed using NCI CTCAE, Version 4.03
  • Pharmacokinetics of G1T28, Carboplatin and Gemcitabine: Maximum Plasma Concentration (Cmax) [ Time Frame: 24 hours ]
    The observed peak plasma concentration determined from the plasma (Tmax)
  • Pharmacokinetics of G1T28, Carboplatin and Gemcitabine: Area under Curve - plasma concentration (AUC) [ Time Frame: 24 hours ]
    Area under the plasma concentration-time curve (AUC)
  • Pharmacokinetics of G1T28, Carboplatin and Gemcitabine: Plasma: terminal half life (T1/2) [ Time Frame: 24 hours ]
    Plasma- terminal half life (T1/2)
  • Pharmacokinetics of G1T28, Carboplatin and Gemcitabine: Plasma - Volume of distribution [ Time Frame: 24 hours ]
    Volume of distribution in the terminal elimination phase (Vz)
  • Incidence of chemotherapy dose reductions [ Time Frame: 18 months ]
  • Incidence of dose interruptions overall [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
Official Title  ICMJE Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
Brief Summary

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer.

The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups:

  • Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)
  • Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30)
  • Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30)

The study will 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Triple-Negative Breast Neoplasms
  • Breast Neoplasm
  • Breast Cancer
  • Triple-Negative Breast Cancer
Intervention  ICMJE
  • Drug: Trilaciclib
    G1T28
    Other Names:
    • G1T28
    • CDK 4/6 Inhibitor
  • Drug: Gemcitabine
    Gemcitabine
  • Drug: Carboplatin
    Carboplatin
Study Arms  ICMJE
  • Experimental: Group 1: Gemcitabine/Carboplatin
    GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 1 and 8 in 21-day cycles.
    Interventions:
    • Drug: Gemcitabine
    • Drug: Carboplatin
  • Experimental: Group 2: Trilaciclib (G1T28) + Gemcitabine/Carboplatin
    Trilaciclib (G1T28) IV prior to GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 1 and 8 in 21-day cycles.
    Interventions:
    • Drug: Trilaciclib
    • Drug: Gemcitabine
    • Drug: Carboplatin
  • Experimental: Group 3: Trilaciclib (G1T28) + Gemcitabine/Carboplatin
    Trilaciclib (G1T28) IV on Days 1, 2, 8 and 9. GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 2 and 9 in 21-day cycles.
    Interventions:
    • Drug: Trilaciclib
    • Drug: Gemcitabine
    • Drug: Carboplatin
Publications * Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnović Ž, Vasev N, Ma L, Richards DA, Wilks ST, Milenković D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Sep 27. pii: S1470-2045(19)30616-3. doi: 10.1016/S1470-2045(19)30616-3. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
102
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
90
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of HR-negative, HER2-negative (locally recurrent or metastatic TNBC) breast cancer
  • Available TNBC diagnostic tumor tissue (archived tissue allowed)
  • Evaluable disease
  • ECOG performance status 0 to 1
  • Adequate organ function
  • Predicted life expectancy of 3 or more months

Exclusion Criteria:

  • More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If ≥ 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence the therapy will not be considered a line of therapy in the locally recurrent or metastatic TNBC setting.
  • CNS metastases or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
  • Investigational drug within 30 days of first trilaciclib (G1T28) dose
  • Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose
  • Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose
  • Prior hematopoietic stem cell or bone marrow transplantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Croatia,   North Macedonia,   Serbia,   Slovakia,   Slovenia,   United States
Removed Location Countries Macedonia, The Former Yugoslav Republic of,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02978716
Other Study ID Numbers  ICMJE G1T28-04
2016-004466-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party G1 Therapeutics, Inc.
Study Sponsor  ICMJE G1 Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Contact G1 Therapeutics, Inc.
PRS Account G1 Therapeutics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP