Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy

Who is this study for? Adult patients with metastatic triple negative breast cancer
What treatments are being studied? Trilaciclib
Status: Terminated
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This was 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 participants with metastatic triple negative breast cancer. The study was an open-label and 102 participants were 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=34) * Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=33) * Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=35) The study included 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of hormone receptor (HR)-negative, human epidermal growth factor receptor 2 (HER2)-negative (locally recurrent or metastatic TNBC) breast cancer

• Available TNBC diagnostic tumor tissue (archived tissue allowed)

• Evaluable disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

• Adequate organ function

• Predicted life expectancy of 3 or more months

Locations
United States
Arizona
Arizona Oncology Associates, PC - HOPE
Tucson
California
Disney Family Cancer Center
Burbank
Sharp Clinical Oncology
San Diego
Innovative Clinical Research Institute
Whittier
Colorado
Memorial UC Health
Colorado Springs
Rocky Mountain Cancer Centers
Lakewood
Florida
Florida Cancer Specialists
Fort Myers
Florida Cancer Research Institute, LLC.
Plantation
Florida Cancer Specialists - North (FCS North)
Saint Petersburg
Moffitt Cancer Center
Tampa
Florida Cancer Specialists - East (FCS East)
West Palm Beach
Idaho
Saint Alphonsus Regional Medical Center
Boise
Illinois
Illinois Cancer Specialists
Arlington Heights
Indiana
Community Health Network
Indianapolis
Maryland
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
The University of Maryland St. Joseph Medical Center
Towson
Missouri
Saint Luke's Cancer Institute
Kansas City
North Carolina
Levine Cancer Center
Charlotte
Forsyth Memorial Hospital, Novant Health Oncology Specialists
Winston-salem
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
Tennessee
Tennessee Oncology
Chattanooga
Tennessee Oncology
Nashville
Texas
Texas Oncology-Dallas Presbyterian Hospital
Austin
Texas Oncology, P.A.
Austin
Texas Oncology, P.A.
Bedford
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso
The Center for Cancer and Blood Disorders
Fort Worth
Texas Oncology-San Antonio Northeast
San Antonio
Texas Oncology, P.A.
Tyler
Tyler Hematology-Oncology, PA
Tyler
Virginia
University of Virginia
Charlottesville
Virginia Cancer Specialists, PC
Fairfax
Virginia Oncology Associates
Virginia Beach
Washington
Northwest Medical Specialties, PLLC
Tacoma
Other Locations
Belgium
Antwerp University Hospital (UZA)
Edegem
Bulgaria
MHAT for Womens Health - Nadezhda OOD
Sofia
Special Hospital For Active Treatment In Oncology
Sofia
University Multiprofile Hospital for Active Treatment
Sofia
Multiprofile Hospital for Active Treatment
Varna
Croatia
University Hospital Centre Osijek
Osijek
General Hospital Varaždin
Varazdin
University Hospital Centre Sestre milosrdnice
Zagreb
University Hospital Centre Zagreb
Zagreb
Serbia
Clinical Hospital Centre Bezanijska Kosa, Oncology Clinic
Belgrade
Special Hospital for Internal Diseases , Oncomed
Belgrade
Center for Oncology and Radiotherapy, Clinical Centre
Kragujevac
Clinical Centre Nis, Clinic of Oncology
Nis
Oncology Institute of Vojvodina, Clinic for Internal Oncology
Sremska Kamenica
Slovakia
Mammacentrum, Sv.Agáty
Banská Bystrica
Cancer Institute VOU, Rastislavova
Košice
Slovenia
University Medical Centre Maribor
Maribor
Time Frame
Start Date: 2017-02-02
Completion Date: 2020-02-28
Participants
Target number of participants: 102
Treatments
Experimental: Group 1: Gemcitabine/Carboplatin (Days 1 and 8)
Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square \[mg/m\^2\] and carboplatin area under the curve \[AUC\] 2) on Days 1 and 8 of 21-day cycle. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
Experimental: Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)
Participants received IV infusion of trilaciclib 240 mg/m\^2 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycle. Trilaciclib was administered prior to chemotherapy.
Experimental: Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)
Participants received IV infusion of trilaciclib 240 mg/m\^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m\^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day Cycle. Trilaciclib was administered prior to chemotherapy.
Sponsors
Leads: G1 Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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