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Last Updated: July 1, 2022

CLINICAL TRIALS PROFILE FOR TRILACICLIB DIHYDROCHLORIDE


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All Clinical Trials for Trilaciclib Dihydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02499770 ↗ Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) Completed G1 Therapeutics, Inc. Phase 1/Phase 2 2015-06-26 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 etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. 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.
NCT02514447 ↗ Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy Active, not recruiting G1 Therapeutics, Inc. Phase 1/Phase 2 2015-10-05 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 topotecan in patients previously treated for extensive-stage SCLC. 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. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.
NCT02978716 ↗ Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) Active, not recruiting G1 Therapeutics, Inc. Phase 2 2017-02-07 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 ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Trilaciclib Dihydrochloride

Condition Name

Condition Name for Trilaciclib Dihydrochloride
Intervention Trials
Breast Cancer 3
Small Cell Lung Cancer 3
Myelosuppression Adult 2
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Condition MeSH

Condition MeSH for Trilaciclib Dihydrochloride
Intervention Trials
Lung Neoplasms 6
Small Cell Lung Carcinoma 5
Breast Neoplasms 4
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Clinical Trial Locations for Trilaciclib Dihydrochloride

Trials by Country

Trials by Country for Trilaciclib Dihydrochloride
Location Trials
United States 121
Spain 10
China 7
United Kingdom 6
Ukraine 6
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Trials by US State

Trials by US State for Trilaciclib Dihydrochloride
Location Trials
California 8
Texas 8
Florida 7
Missouri 6
Virginia 6
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Clinical Trial Progress for Trilaciclib Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Trilaciclib Dihydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Trilaciclib Dihydrochloride
Clinical Trial Phase Trials
Recruiting 6
Active, not recruiting 3
Not yet recruiting 2
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Clinical Trial Sponsors for Trilaciclib Dihydrochloride

Sponsor Name

Sponsor Name for Trilaciclib Dihydrochloride
Sponsor Trials
G1 Therapeutics, Inc. 12
Jiangsu Simcere Pharmaceutical Co., Ltd. 2
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Sponsor Type

Sponsor Type for Trilaciclib Dihydrochloride
Sponsor Trials
Industry 14
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