Description:
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.
Title
- Brief Title: Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
- 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
Clinical Trial IDs
- ORG STUDY ID:
G1T28-04
- SECONDARY ID:
2016-004466-26
- NCT ID:
NCT02978716
Conditions
- Triple-Negative Breast Neoplasms
- Breast Neoplasm
- Breast Cancer
- Triple-Negative Breast Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Trilaciclib | G1T28, CDK 4/6 Inhibitor | Group 2: Trilaciclib (G1T28) + Gemcitabine/Carboplatin |
| Gemcitabine | | Group 1: Gemcitabine/Carboplatin |
| Carboplatin | | Group 1: Gemcitabine/Carboplatin |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Group 1: Gemcitabine/Carboplatin | Experimental | GC chemotherapy (gemcitabine 1000 mg/m2 and carboplatin AUC = 2 administered IV) on Days 1 and 8 in 21-day cycles. | |
| Group 2: Trilaciclib (G1T28) + Gemcitabine/Carboplatin | Experimental | 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. | - Trilaciclib
- Gemcitabine
- Carboplatin
|
| Group 3: Trilaciclib (G1T28) + Gemcitabine/Carboplatin | Experimental | 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. | - Trilaciclib
- Gemcitabine
- Carboplatin
|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Treatment Related Adverse Event, including Abnormal Laboratory Events |
| Time Frame: | 18 months |
| Safety Issue: | |
| Description: | 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
| Measure: | Tumor response based on RECIST, Version 1.1 |
| Time Frame: | 18 months |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival (PFS) |
| Time Frame: | 27 months |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival (OS) |
| Time Frame: | 36 months |
| Safety Issue: | |
| Description: | |
| Measure: | Hematologic parameters |
| Time Frame: | 18 months |
| Safety Issue: | |
| Description: | Number of patients with treatment related abnormal laboratory assessments. Laboratory toxicities will be assessed using NCI CTCAE, Version 4.03 |
| Measure: | Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Maximum Plasma Concentration (Cmax) |
| Time Frame: | 24 hours |
| Safety Issue: | |
| Description: | The observed peak plasma concentration determined from the plasma (Cmax) |
| Measure: | Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Area under Curve - plasma concentration (AUC) |
| Time Frame: | 24 hours |
| Safety Issue: | |
| Description: | Area under the plasma concentration-time curve (AUC) |
| Measure: | Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma: terminal half life (T1/2) |
| Time Frame: | 24 hours |
| Safety Issue: | |
| Description: | Plasma- terminal half life (T1/2) |
| Measure: | Pharmacokinetics of Trilaciclib (G1T28), Carboplatin and Gemcitabine: Plasma - Volume of distribution |
| Time Frame: | 24 hours |
| Safety Issue: | |
| Description: | Volume of distribution in the terminal elimination phase (Vz) |
| Measure: | Incidence of chemotherapy dose reductions |
| Time Frame: | 18 months |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of dose interruptions overall |
| Time Frame: | 18 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | G1 Therapeutics, Inc. |
Trial Keywords
- Breast Cancer
- CDK 4/6 Inhibitor
- Triple Negative Breast Cancer
- Metastatic
Last Updated
January 27, 2021
