Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2018 |
| Start Date: | February 7, 2017 |
| End Date: | February 2020 |
Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
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.
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.
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
We found this trial at
36
sites
3840 Broadway
Fort Myers, Florida 33901
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Lowell Hart, MD
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Arlington Heights, Illinois 60005
Principal Investigator: Urszula Sobol, MD
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8196 Walnut Hill Lane
Austin, Texas 75231
Austin, Texas 75231
Principal Investigator: Kristi J. McIntyre, MD
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Principal Investigator: Katherine Tkaczuk, MD
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1055 N Curtis Rd
Boise, Idaho 83706
Boise, Idaho 83706
(208) 367-2121
Principal Investigator: Kerry Pulver, MD
Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Patrick Dillon, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Principal Investigator: Uchenna Njiaju, MD
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Dallas, Texas 75246
Principal Investigator: Joyce A. O'Shaughnessy, MD
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El Paso, Texas 79902
Principal Investigator: Ines J. Sanchez-Rivera, MD
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Anne M. Favret, MD
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Worth, Texas 76104
Principal Investigator: Robyn Young, MD
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4321 Washington Street #4000
Kansas City, Missouri 64111
Kansas City, Missouri 64111
(816) 932-3300
Principal Investigator: Timothy Pluard, MD
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Anu R. Thummala, MD
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Denise Yardley, MD
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Principal Investigator: Gail Wright, MD
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San Antonio, Texas 78217
Principal Investigator: Sharon T. Wilks, MD
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2929 Health Center Drive
San Diego, California 92123
San Diego, California 92123
Principal Investigator: Reema Batra, MD
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Towson, Maryland 21201
Principal Investigator: Rima Couzi, MD
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Tucson, Arizona 85704
Principal Investigator: Rachel Swart, MD
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Virginia Beach, Virginia 23456
Principal Investigator: Michael A. Danso, MD
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1309 North Flagler Drive
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
Principal Investigator: Eric Harris, MD
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Whittier, California 90603
Principal Investigator: Eric Cheung, MD
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3333 Silas Creek Parkway
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Principal Investigator: Judith Hopkins, MD
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