Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Talon Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT00145041

First received: September 1, 2005

Last updated: January 23, 2012

Last verified: January 2012

History of Changes

Results First Received: November 29, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Malignant Melanoma
Intervention:	Drug: Vincristine Sulfate Liposomes Injection

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Overall Study
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Overall Study
Number of Participants [units: participants]	7
Age [units: participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	3
Age [units: years] Mean ± Standard Deviation	60.7 ± 8.10
Gender [units: participants]
Female	4
Male	3
Region of Enrollment [units: participants]
United States	7

Outcome Measures

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1. Primary:

T 1/2 [ Time Frame: cycle 1 day 1 ]

Measure Type	Primary
Measure Title	T 1/2
Measure Description	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.
Time Frame	cycle 1 day 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
all patients enrolled

Reporting Groups

	Description
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.

Measured Values

	Overall Study
Number of Participants Analyzed [units: participants]	7
T 1/2 [units: hr] Mean ± Standard Deviation	9.94 ± 1.22

No statistical analysis provided for T 1/2

2. Primary:

Clearance [ Time Frame: Day 1 of Cycle 1 ]

Measure Type	Primary
Measure Title	Clearance
Measure Description	The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2
Time Frame	Day 1 of Cycle 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects enrolled

Reporting Groups

	Description
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.

Measured Values

	Overall Study
Number of Participants Analyzed [units: participants]	7
Clearance [units: ml/h/m2] Mean ± Standard Deviation	193 ± 80.3

No statistical analysis provided for Clearance

3. Primary:

Volume of Distribution [ Time Frame: cycle 1 day 1 ]

Measure Type	Primary
Measure Title	Volume of Distribution
Measure Description	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
Time Frame	cycle 1 day 1
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
all patients enrolled

Reporting Groups

	Description
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.

Measured Values

	Overall Study
Number of Participants Analyzed [units: participants]	7
Volume of Distribution [units: mL/m2] Mean ± Standard Deviation	2722 ± 1066

No statistical analysis provided for Volume of Distribution

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The dose administered to subjects with impaired liver function was ~1 mg/m2 which is lower than is administered to subjects with normal liver function (2 mg/m2). The impact of liver impairment on that higher dose remains unknown.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Talon Therapeutics
phone: 650-588-6404
e-mail: info@talontx.com

No publications provided

Responsible Party:	Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00145041 History of Changes
Other Study ID Numbers:	VSLI-12-HEPHARM
Study First Received:	September 1, 2005
Results First Received:	November 29, 2011
Last Updated:	January 23, 2012
Health Authority:	United States: Food and Drug Administration

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