Trial Outcomes & Findings for Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer (NCT NCT05113966)
NCT ID: NCT05113966
Last Updated: 2025-01-29
Results Overview
Progression free survival was defined as the time (months) from the date of the first dose of the study drug to the date of documented radiographic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to approximately 23 months
Results posted on
2025-01-29
Participant Flow
Recruitment took place from Q4 2021 until Q2 2024 in 20 different centers.
The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of the first study treatment dose and was completed at the Safety Follow-up Visit. The first Survival Follow-up assessment occurred approximately 3 months after the Safety Follow-Up Visit.
Participant milestones
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
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|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Study Terminated by Sponsor
|
9
|
Baseline Characteristics
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 11.09 • n=99 Participants
|
|
Sex/Gender, Customized
Sex at Birth: Female
|
30 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 23 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
Progression free survival was defined as the time (months) from the date of the first dose of the study drug to the date of documented radiographic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
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|---|---|
|
Progression Free Survival (PFS)
|
4.1 months
Interval 2.2 to 7.3
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The Response Evaluable (RE) population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) do not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan.
ORR was defined as the percentage of participants with the best overall response of confirmed complete response or confirmed partial response per RECIST v1.1 Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
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|---|---|
|
Objective Response Rate (ORR)
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: RE: population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan.
CBR was defined as the percentage of participants with the 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
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
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|---|---|
|
Clinical Benefit Rate (CBR)
|
46.7 percentage of participants
Interval 28.3 to 65.7
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: The Response Evaluable (RE) population included all participants who were in the FAS and who had measurable (target) tumor lesion(s) at the baseline tumor assessment and either (i) had at least 1 post-baseline tumor assessment, or (ii) did not have post-dose tumor assessment but had clinical progression as noted by the Investigator, or (iii) died due to disease progression prior to their first post-baseline tumor scan. DOR was only analyzed for the participants who had achieved OR.
DOR was the time between the first objective response of CR or PR (confirmed) and the first date that progressive disease was documented or death, whichever comes first. DOR was only analyzed for the patients who had achieved objective responses.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=7 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Duration of Objective Response (DOR)
|
8.8 months
Interval 4.0 to
Not evaluable due to the low number of responders.
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
OS was defined as the time (months) from the date of the first dose of the study drug to the date of death for participants who died in the study due to any cause or the time to the last contact date known to be alive for those participants who survived as of the data cutoff date for the planned OS analysis (censored cases).
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Overall Survival (OS)
|
15.9 months
Interval 9.9 to 20.9
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
Occurrences of SN in Cycles 1 and 2 and the overall study are reported.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
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|---|---|
|
Number of Participants With Occurrence of Severe Neutropenia (SN)
Participants with At Least 1 Event During Cycles 1-2 · No
|
29 Participants
|
|
Number of Participants With Occurrence of Severe Neutropenia (SN)
Participants with At Least 1 Event During Cycles 1-2 · Yes
|
1 Participants
|
|
Number of Participants With Occurrence of Severe Neutropenia (SN)
Participants with At Least 1 Event During Overall Study · No
|
29 Participants
|
|
Number of Participants With Occurrence of Severe Neutropenia (SN)
Participants with At Least 1 Event During Overall Study · Yes
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
FN was defined as a complication of cancer treatment. It is the development of a fever, alongside other signs of infection such as feeling unwell, shivers, and shakes in a participant with neutropenia.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Participants With At Least One Occurrence of Febrile Neutropenia (FN)
No
|
29 Participants
|
|
Participants With At Least One Occurrence of Febrile Neutropenia (FN)
Yes
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
The number of cycles with G-CSF administrations for a participant was the total number of cycles where the participant received at least one dose of G-CSF, for participants who did not have any G-CSF use and those who were enrolled but did not receive any study treatment, a value of 0 was assigned.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Occurrence of Granulocyte Colony-stimulating Factor (G-CSF) Administration
Participants with At Least One Event - Yes
|
7 Participants
|
|
Occurrence of Granulocyte Colony-stimulating Factor (G-CSF) Administration
Participants with At Least One Event - No
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: FAS: included all enrolled participants who were administered at least 1 dose of study drug.
The occurrence of Grade 3 or 4 decreased hemoglobin (Hgb) for a participant was defined as having at least one Hgb value that was \< 8.0 gram per deciliter (g/dL) among all scheduled or unscheduled assessments. It was a binary random variable (Yes or No).
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Occurrence of Grade 3 or 4 Decreased Hemoglobin (Hgb)
No
|
30 Participants
|
|
Occurrence of Grade 3 or 4 Decreased Hemoglobin (Hgb)
Yes
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 5 up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
Based on the NCCN Clinical Practice Guidelines in Oncology for Hematopoietic Growth Factors Version 2.2020 and the AABB Clinical Practice Guidelines, the following RBC transfusion thresholds were recommended; however, the participant's clinical situation should always be the primary guiding factor when deciding to transfuse. * Transfusion is not indicated until the hemoglobin level is ≤7 g/dL for hospitalized adult hemodynamically stable participants . * An RBC transfusion threshold of ≤8 g/dL is recommended for participants undergoing orthopedic surgery, cardiac surgery, and those with preexisting cardiovascular disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
If participants experienced chemotherapy-induced anemia (hemoglobin level \<10 g/dL) after receiving the first dose of study treatment, ESAs may be used per ASCO guidelines to improve hematopoietic response and reduce the likelihood of RBC transfusion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
Grade 3 shows signs of mucosal bleeding, such as blood crusting in nostrils or nosebleeds, petechiae or purpura in the mouth, blood in the urine or stool, and heavy periods. Grade 4 shows signs of more severe mucosal bleeding or suspected internal bleeding, such as in the brain or lungs that requires immediate medical attention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
Platelet transfusion is recommended at a threshold of ≤10 x 10\^9/L. Platelets should also be transfused in any participant who was bleeding with a platelet count \<50 x 10\^9/L (100 x 10\^9/L for central nervous system or ocular bleeding).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
Participants experienced chemotherapy-induced myelosuppression faced severe clinical consequences such as serious infections are reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 24 monthsPopulation: Data were not collected for this outcome measure nor conducted as part of the final analysis as they were not deemed critical for the aCSR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first administration of study treatment (Day 1) up to approximately 24 monthsPopulation: Safety Population; included all enrolled participants who received at least 1 dose of study drug.
AEs are defined as those events occurring or worsening after treatment has begun in the study. An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 Participants
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Non-serious Adverse Events (NSAEs)
Number of Participants with Any AE
|
29 Count of participants
|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Non-serious Adverse Events (NSAEs)
Number of Participants with Any Serious AE
|
6 Count of participants
|
Adverse Events
Trilaciclib + Sacituzumab Govitecan-hziy
Serious events: 6 serious events
Other events: 29 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 participants at risk
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Infections and infestations
Breast cellulitis
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.3%
1/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Trilaciclib + Sacituzumab Govitecan-hziy
n=30 participants at risk
Participants received trilaciclib + sacituzumab govitecan-hziy on Days 1 and 8 of a 21-day cycle. Trilaciclib was administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Trilaciclib: Single-use, sterile powder reconstituted and further diluted with 250 mL of normal saline (sodium chloride solution 0.9%) or D5W Sacituzumab Govitecan-hziy: 10 mg/kg reconstituted to a concentration of 1.1 mg/mL to 3.4 mg/mL in normal saline
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
53.3%
16/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.3%
13/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
9/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
8/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
63.3%
19/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Localised oedema
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
10/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
5/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chest wall necrosis
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.7%
11/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
16.7%
5/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
23.3%
7/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count decreased
|
23.3%
7/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
23.3%
7/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
6/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
3/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
13.3%
4/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • From the first administration of study treatment (Day 1) up to the end of the study visit, approximately 132 weeks.
The safety population included all enrolled participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agrees to submit any disclosure to Sponsor for review at least thirty (30) days prior to submission. Within sixty (60) days of its receipt, Sponsor can provide feedback on any disclosure Sponsor may require Investigator to remove, Confidential Information (other than study data), and/or to delay the proposed publication or presentation for an additional sixty (60) days to enable Sponsor to seek patent protection for inventions.
- Publication restrictions are in place
Restriction type: OTHER