- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113966
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
March 21, 2024 updated by: G1 Therapeutics, Inc.
Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting
This is a Phase 2, multicenter, open-label, single arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase.
The Treatment Phase begins on the day of the first dose of study treatment and completes at the Safety Follow-up Visit.
Trilaciclib and sacituzumab govitecan-hziy will be administered intravenously (IV) in 21-day cycles.
Study drug administration will continue until progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or clinical progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the study, whichever occurs first.
The first Survival Follow-up assessment should occur approximately 3 months after the Safety Follow-Up Visit and will continue every 3 months until the end of the study (or death).
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Chandler, Arizona, United States, 85224
- Ironwood Physicians
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California
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Bakersfield, California, United States, 93309
- Comprehensive Blood & Cancer Center
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Los Angeles, California, United States, 90017
- Los Angeles Hematology Oncology Medical Group
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Los Angeles, California, United States, 90067
- Valkyrie Clinical Trials
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Santa Monica, California, United States, 90404
- UCLA Hematology/Oncology Parkside
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Whittier, California, United States, 90602
- PIH Health
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Colorado
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Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers
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Florida
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Hollywood, Florida, United States, 33021
- Memorial Healthcare System
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Orlando, Florida, United States, 32806
- Orlando Health Cancer Institute
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Illinois
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Joliet, Illinois, United States, 60435
- Duly Health and Care
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Maine
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Scarborough, Maine, United States, 04704
- New England Cancer Specialists
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Minnesota
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Woodbury, Minnesota, United States, 55125
- Minnesota Oncology Hematology, P.A.
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Nevada
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Las Vegas, Nevada, United States, 89128
- Comprehensive Cancer Centers of Nevada
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Oregon
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Tigard, Oregon, United States, 97223
- Northwest Cancer Specialists, PC
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Texas
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Austin, Texas, United States, 78731
- Texas Oncology - Austin Central
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Dallas, Texas, United States, 75246
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Longview, Texas, United States, 75601
- Texas Oncology - Longview Cancer Center
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Virginia
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Fairfax, Virginia, United States, 22031
- Inova Schar Cancer Institute
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc
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Washington
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Auburn, Washington, United States, 98001
- MultiCare Health System
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Tacoma, Washington, United States, 98405
- Northwest Medical Specialties, PLLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult ( ≥18 years of age), fFemale or male patient with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC
- Documentation of histologically or cytologically confirmed ER-negative, PR-negative, and HER2-negative tumor per the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (ASCO/CAP) criteria.
Patient must have had documented disease progression during or after 2 lines of systemic chemotherapy treatment for unresectable, locally advanced or metastatic breast cancer (these regimens will qualify regardless of TNBC status at the time they were administered):
- One prior line of chemotherapy treatment could be in the neoadjuvant or adjuvant setting if progression occurred within 12 months of completion of chemotherapy;
- Patients must have prior taxane treatment in either the neoadjuvant, adjuvant, or advanced/metastatic setting OR patients must have demonstrated contraindications or are intolerant to taxanes;
- PARP inhibitors may meet the criteria for one of two lines of therapy if patient has documented germline BRCA1/BRCA2 mutation.
- ECOG performance status of 0 or 1.
Adequate organ function as demonstrated by the following laboratory values:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1.5 × 109/L;
- Platelet count ≥100 × 109/L;
- Estimated glomerular filtration rate ≥30 mL/minute/1.73 m2;
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
- ALT and AST ≤3 × ULN in the absence of liver metastasis or ≤5 × ULN in the presence of liver metastasis.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Exclusion Criteria:
- Prior treatment with trilaciclib, sacituzumab govitecan-hziy, irinotecan, Trop-2 antibody drug conjugate, or any therapy with a topoisomerase-1 payload.
- Patients with known brain metastasis at enrollment.
- Patients with known Gilbert's disease or known homozygous for the UGT1A1*28 allele.
- Patients with bone-only disease.
- Malignancies other than TNBC within 3 years prior to enrollment.
- History of clinically significant gastrointestinal bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of enrollment.
- Receipt of any high dose systemic corticosteroids within 2 weeks prior to the first dose of study treatment.
- Current use of immunosuppressive medication.
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association functional classification system).
- History of stroke or cerebrovascular accident within 6 months prior to first dose of study treatment.
- Serious active infection or severe infection within 4 weeks prior to enrollment.
- Prior hematopoietic stem cell or bone marrow transplantation.
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trilaciclib + Sacituzumab Govitecan-hziy
During the Treatment Phase patients will receive trilaciclib + sacituzumab govitecan-hziy on days 1 & 8 of a 21 day cycle.
Trilaciclib is administered first, followed by sacituzumab govitecan-hziy.
Administer diluted trilaciclib solution as a 30-minute IV infusion to be completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
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Single-use, sterile powder to be reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or dextrose 5% in water (D5W)
Other Names:
10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Up to 24 months
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Progression free survival defined as time from the date of first dose of study drug to radiographic disease progression using RECIST v1.1 or death due to any cause, whichever occurs first; for patients without disease progression or death, PFS will be calculated per censoring rules.
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Up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Up to 36 months
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Objective response rate defined as the percentage of patients with best overall response of confirmed complete response or confirmed partial response per RECIST v1.1
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Up to 36 months
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Clinical benefit rate
Time Frame: Up to 36 months
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Clinical benefit rate defined as the percentage of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease lasting 24 weeks or longer since the first date of study drug administration per RECIST v1.1
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Up to 36 months
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Overall survival
Time Frame: Up to 36 months
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Overall survival defined as time from the date of first dose of study drug to death due to any cause for those who died; or time to last contact known as alive for those who survived in the study (censored cases)
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Up to 36 months
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Neutrophil-related myeloprotective effects
Time Frame: Up to 24 months
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Occurrence of severe neutropenia (in Cycles 1/2 and the overall on study), occurrence of febrile neutropenia AEs , and occurrence of G-CSF administration
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Up to 24 months
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RBC -related myeloprotective effects
Time Frame: Up to 24 months
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Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of ESA administration
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Up to 24 months
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Platelet-related myeloprotective effects
Time Frame: Up to 24 months
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Occurrence of Grade 3/4 decrease of platelets and occurrence and number of platelet transfusions
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Up to 24 months
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Safety and tolerability of trilaciclib
Time Frame: Up to 36 months
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Occurrence and severity of AEs by NCI CTCAE v5.0
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Up to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Conduct, G1 Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2021
Primary Completion (Actual)
November 20, 2023
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
October 18, 2021
First Submitted That Met QC Criteria
October 29, 2021
First Posted (Actual)
November 9, 2021
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G1T28-213
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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