Trial Outcomes & Findings for Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy (NCT NCT04465760)
NCT ID: NCT04465760
Last Updated: 2024-01-24
Results Overview
The incidence of overall CAT (inclusive of both symptomatic and asymptomatic events) will be assessed and reported with 95% confidence interval.
TERMINATED
PHASE2
9 participants
Up to end of treatment visit (day 18)
2024-01-24
Participant Flow
Participant milestones
| Measure |
Supportive Care (Xisomab 3G3)
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=93 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=93 Participants
|
|
Age, Customized
50-59 years
|
3 Participants
n=93 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to end of treatment visit (day 18)Population: Eight of nine participants underwent screening ultrasound for catheter thrombosis. One patient had their catheter removed prior to screening ultrasound.
The incidence of overall CAT (inclusive of both symptomatic and asymptomatic events) will be assessed and reported with 95% confidence interval.
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=8 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Incidence of Catheter-associated Thrombosis (CAT)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to end of follow-up (60 days from time of administration)Bleeding will be defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients (i.e., fatal bleeding, critical organ bleeding such as central nervous system bleeding, or bleeding causing a fall in hemoglobin of 20 g/L or more) and clinically relevant non-major bleeding (i.e., bleeding that does not fit the former definition of major bleeding but prompts medical attention). The incidence of major and clinically relevant non-major bleeding, along with 95% confidence interval, will be assessed using the safety analysis set (all patients who are exposed to the single dose of study drug).
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Incidence of Major and Clinically-relevant Bleeding
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to end of follow-up (60 days from time of administration)Descriptive statistics of safety will be presented using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 using the safety analysis set (all patients who are exposed to the single dose of study drug). All on-study AEs, treatment-related AEs, serious adverse events (SAEs), and treatment-related SAEs will be tabulated using worst grade per National Cancer Institute (NCI) CTCAE v5.0 criteria by system organ class and preferred term. On-study lab parameters including hematology, chemistry, liver function, and renal function will be summarized using worst grade NCI CTCAE v5.0 criteria.
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Incidence of Xisomab 3G3-associated Adverse Events (AEs)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment visit (day 18)Presented with descriptive statistics.
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Quantification of Coagulation Measures: Platelet Count
|
275 cells*K/mm^3
Standard Deviation 68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment visit (day 18)Presented with descriptive statistics.
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Quantification of Coagulation Measures: Prothrombin Time/International Normalized Ratio (PT/INR)
|
1.01 INR
Standard Deviation 0.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment visit (day 18)Presented with descriptive statistics.
Outcome measures
| Measure |
Supportive Care (Xisomab 3G3)
n=9 Participants
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Quantification of Coagulation Measures: Activated Partial Thromboplastin Time (aPTT)
|
50.76 Seconds
Standard Deviation 2.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment visit (day 18)Presented with descriptive statistics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From xisomab 3G3 infusion up to end of treatment visit (day 18)Population: No participants developed symptomatic CAT.
Will be reported for those (expected few) subjects with symptomatic CAT.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From xisomab 3G3 infusion up to end of treatment visit (day 18)Population: No participants developed symptomatic CAT.
Will be reported for those (expected few) subjects with symptomatic CAT.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment visit (day 18)Population: No participants developed catheter occlusion requiring medical intervention prior to the end of treatment visit.
Results will be presented with descriptive statistics.
Outcome measures
Outcome data not reported
Adverse Events
Supportive Care (Xisomab 3G3)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supportive Care (Xisomab 3G3)
n=9 participants at risk
Patients receive xisomab 3G3 IV or via catheter within 48 hours of catheter placement. Patients then receive standard of care chemotherapy 2 days later. After approximately 2 weeks, patients undergo standard of care ultrasound for possible CAT.
Xisomab 3G3: Given IV or via catheter
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Reproductive system and breast disorders
Vaginal yeast infection
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
GI upset
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Access site pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Access site erythema
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Peripheral neuropathy
|
22.2%
2/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Cold sensitivity
|
55.6%
5/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Access site bruise
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Arm pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Gum bleeding
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Vascular disorders
Epistaxis
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
4/9 • 30 days post administration of the study drug.
|
|
Cardiac disorders
Hypertension
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Rectal bleeding
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • 30 days post administration of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Jaw pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Eye disorders
Eye floaters
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Injury, poisoning and procedural complications
Postoperative pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Nervous system disorders
Non cardiac- chest pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
General disorders
Fatigue
|
33.3%
3/9 • 30 days post administration of the study drug.
|
|
Metabolism and nutrition disorders
Loss of appetite
|
22.2%
2/9 • 30 days post administration of the study drug.
|
|
General disorders
Lower extremity edema
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
General disorders
Shoulder pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
General disorders
Joint pain
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
General disorders
Body Ache
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
11.1%
1/9 • 30 days post administration of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
11.1%
1/9 • 30 days post administration of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place