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 : Recruiting
First Posted : December 1, 2016
Last Update Posted : December 11, 2017
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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 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.
Other Names: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.
Other Names:Drug: Gemcitabine Drug: Carboplatin
- 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
- 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 ]
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
|Contact: G1 Therapeutics Clinical Contactfirstname.lastname@example.org|
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|Study Director:||Clinical Contact||G1 Therapeutics, Inc.|