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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Triple-Negative Breast Neoplasms Breast Neoplasm Breast Cancer Triple-Negative Breast Cancer Drug: Trilaciclib Drug: Gemcitabine Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : July 30, 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Gemcitabine
Gemcitabine

Drug: Carboplatin
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.
 Drug: Trilaciclib
G1T28
Other Names:
  • G1T28
  • CDK 4/6 Inhibitor

Drug: Gemcitabine
Gemcitabine

Drug: Carboplatin
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.
 Drug: Trilaciclib
G1T28
Other Names:
  • G1T28
  • CDK 4/6 Inhibitor

Drug: Gemcitabine
Gemcitabine

Drug: Carboplatin
Carboplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Tumor response based on RECIST, Version 1.1 [ Time Frame: 18 months ]
  2. Progression free survival (PFS) [ Time Frame: 27 months ]
  3. Overall survival (OS) [ Time Frame: 36 months ]
  4. 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

  5. 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)

  6. 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)

  7. Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma: terminal half life (T1/2) [ Time Frame: 24 hours ]
    Plasma- terminal half life (T1/2)

  8. Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma - Volume of distribution [ Time Frame: 24 hours ]
    Volume of distribution in the terminal elimination phase (Vz)

  9. Incidence of chemotherapy dose reductions [ Time Frame: 18 months ]
  10. Incidence of dose interruptions overall [ Time Frame: 18 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978716


Locations
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Sponsors and Collaborators
G1 Therapeutics, Inc.
Investigators
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Study Director: Clinical Contact G1 Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: G1 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02978716    
Other Study ID Numbers: G1T28-04
2016-004466-26 ( EudraCT Number )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by G1 Therapeutics, Inc.:
Breast Cancer
CDK 4/6 Inhibitor
Triple Negative Breast Cancer
Metastatic
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs