Trial Outcomes & Findings for Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT02337478)
NCT ID: NCT02337478
Last Updated: 2019-08-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 56 days
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Treatment (Vincristine Sulfate Liposome)
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Vincristine Sulfate Liposome)
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
Baseline Characteristics
Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 Participants
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 56 daysOutcome measures
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 Participants
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Number of Participants Able to Complete Two or More Courses of Therapy Regardless of Dose Modifications
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after completion of study treatmentConfidence intervals will be calculated around the estimates of the response rate (CR, CRi, PR, and MLFS) of VSLI. Assuming a response rate of 0.1, with 39 participants, 95 percent confidence intervals with a 0.09 margin of error (0.01, 0.19) or a margin of error of 0.16 around a response rate of 0.5 will be created. (Complete remission (CR) bone marrow blasts \<5%, absence of blasts with Auer rods; absence of extramedullary disease, absolute neutrophil count \>1,000, platelet count \>100,000, independence of red cell transfusions; Complete remission with incomplete recovery (CRi) all complete remission except for residual neutropenia or thrombocytopenia; partial remission (PR), decrease of bone marrow blast to 5-25%, decrease of pre-treatment bone marrow blast by at least 50%; morphologic leukemia-free state (MLFS) Bone marrow blasts \<5%, absence of Aeur rods, absence of extramedullary disease, no hematologic recovery required).
Outcome measures
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 Participants
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Response Rate (CR, CRi, PR, and MLFS)
No response
|
5 Participants
|
|
Response Rate (CR, CRi, PR, and MLFS)
Complete response
|
0 Participants
|
|
Response Rate (CR, CRi, PR, and MLFS)
Complete reponse (incomplete)
|
0 Participants
|
|
Response Rate (CR, CRi, PR, and MLFS)
Partial response
|
0 Participants
|
|
Response Rate (CR, CRi, PR, and MLFS)
Morphologic leukemia free state
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after completion of therapyKaplan-Meier estimation will be used to analyze overall survival.
Outcome measures
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 Participants
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
1.5 months
Interval 1.0 to 11.6
|
Adverse Events
Treatment (Vincristine Sulfate Liposome)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 participants at risk
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
General disorders
Death
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
Other adverse events
| Measure |
Treatment (Vincristine Sulfate Liposome)
n=5 participants at risk
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Vincristine Sulfate Liposome: Given via injection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Agitation
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Alkalosis
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
5/5 • Number of events 6 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
5/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Anxiety
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Bloating
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Injury, poisoning and procedural complications
Bruising
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Cardiac disorders
Cardiac disorders, other
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Cardiac troponin I increased
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Infections and infestations
Catheter related infection
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Chills
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Renal and urinary disorders
Chronic kidney disease
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Confusion
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Delirium
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Dizziness
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Dry mouth
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Edema limbs
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
20.0%
1/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
General disorders and administration site conditions - Other
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
100.0%
5/5 • Number of events 6 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
5/5 • Number of events 6 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypokalemia
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
5/5 • Number of events 6 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Hypophosphastemia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Psychiatric disorders
Insomnia
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Investigations - other
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Lethargy
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Lymphocyte count decreased
|
100.0%
5/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Infections and infestations
Mucosal infection
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Nausea
|
100.0%
5/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Nervous system disorders Other
|
20.0%
1/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Neutrophil count decreased
|
80.0%
4/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Non-cardiac chest pain
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
General disorders
Pain
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
80.0%
4/5 • Number of events 4 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
Platelet count decreased
|
80.0%
4/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Nervous system disorders
Presyncope
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Reproductive system and breast disorders
Reproductive system and breast disorder - other
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorder - other
|
40.0%
2/5 • Number of events 2 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Eye disorders
Scleral disorder
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Cardiac disorders
Sinus tachycardia
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - other
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Infections and infestations
Skin infection
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Cardiac disorders
Ventricular arrhythmia
|
20.0%
1/5 • Number of events 1 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Metabolism and nutrition disorders
Weight loss
|
60.0%
3/5 • Number of events 3 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
|
Investigations
White blood cell decreased
|
80.0%
4/5 • Number of events 5 • Over 6 months
Adverse events were captured for 8 days after the last dose of Vincristine Sulfate Liposome Injection (VSLI). Serious adverse events includes all Grade 5 and unexpected Grade 4 toxicities
|
Additional Information
Timothy Pardee, MD, Ph.D.
Wake Forest University Health Sciences
Phone: 336-716-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place