Trial Outcomes & Findings for Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction (NCT NCT00145041)
NCT ID: NCT00145041
Last Updated: 2019-12-12
Results Overview
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
cycle 1 day 1
Results posted on
2019-12-12
Participant Flow
This was a single-center, open-label, single-arm, Phase 1 study to assess the PK of VSLI in subjects with malignant melanoma and hepatic dysfunction secondary to liver metastases.
Eligible subjects were to have liver metastases confirmed by computed tomography (CT) scan at screening. Categorization of hepatic dysfunction at screening included Child-Pugh System.
Participant milestones
| Measure |
Overall Study
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction
Baseline characteristics by cohort
| Measure |
Overall Study
n=7 Participants
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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4 Participants
n=5 Participants
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Age, Categorical
>=65 years
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3 Participants
n=5 Participants
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Age, Continuous
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60.7 years
STANDARD_DEVIATION 8.10 • n=5 Participants
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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7 participants
n=5 Participants
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PRIMARY outcome
Timeframe: cycle 1 day 1Population: all patients enrolled
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.
Outcome measures
| Measure |
Overall Study
n=7 Participants
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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T 1/2
|
9.94 hr
Standard Deviation 1.22
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PRIMARY outcome
Timeframe: Day 1 of Cycle 1Population: All subjects enrolled
The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2
Outcome measures
| Measure |
Overall Study
n=7 Participants
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Clearance
|
193 ml/h/m2
Standard Deviation 80.3
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PRIMARY outcome
Timeframe: cycle 1 day 1Population: all patients enrolled
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour
Outcome measures
| Measure |
Overall Study
n=7 Participants
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Volume of Distribution
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2722 mL/m2
Standard Deviation 1066
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Adverse Events
Overall Study
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Study
n=7 participants at risk
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Cardiac disorders
Cardiac arrest
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Multi-organ failure
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Skin and subcutaneous tissue disorders
Malignant melanoma
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42.9%
3/7 • Number of events 3 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Ascites
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Gastrointestinal disorders
Constipation
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Abdominal pain upper
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Skin and subcutaneous tissue disorders
Disease progression
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Other adverse events
| Measure |
Overall Study
n=7 participants at risk
This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
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|---|---|
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Skin and subcutaneous tissue disorders
Malignant melanoma
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57.1%
4/7 • Number of events 4 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Fatigue
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57.1%
4/7 • Number of events 4 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Decreased appetite
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57.1%
4/7 • Number of events 4 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Ascites
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42.9%
3/7 • Number of events 3 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Gastrointestinal disorders
Constipation
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42.9%
3/7 • Number of events 3 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Nausea
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42.9%
3/7 • Number of events 3 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Oedema, peripheral
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28.6%
2/7 • Number of events 2 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Pyrexia
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28.6%
2/7 • Number of events 2 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Nervous system disorders
Anxiety
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28.6%
2/7 • Number of events 2 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Insomnia
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28.6%
2/7 • Number of events 2 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Abdominal distention
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Abdominal pain, upper
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Gastrointestinal disorders
Vomitting
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Nervous system disorders
Gait disturbance
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Multi-organ failure
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Oedema
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Hypomagnesaemia
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
Hyponatraemia
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
tumor pain
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Nervous system disorders
confusional state
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Nervous system disorders
depression
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
sleep disorder
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Respiratory, thoracic and mediastinal disorders
pleural effusion
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
|
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Blood and lymphatic system disorders
anaemia
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Blood and lymphatic system disorders
disseminated intravascular coagulation
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
drug hypersensitivity
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
seasonal allergy
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Hepatobiliary disorders
blood bilirubin increased
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
weight increased
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Musculoskeletal and connective tissue disorders
arthralgia
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Musculoskeletal and connective tissue disorders
rheumatoid arthritis
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Cardiac disorders
cardiac arrest
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Hepatobiliary disorders
hyperbilirubinaenemia
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Infections and infestations
central line infection
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Nervous system disorders
neuropathy, peripheral
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14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
night sweats
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Skin and subcutaneous tissue disorders
rash
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
menopause
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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General disorders
hypotension
|
14.3%
1/7 • Number of events 1 • The AE reporting period for this study was from the time of the first dose of VSLI until 30 days after the last dose of VSLI.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60