Pharmacokinetics Study of Liposomal Paclitaxel in Humans | NCT00606515

Studies
Pharmacokinetics Study of Liposomal Paclitaxel in Humans

NCT00606515

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Feb 10, 2009Estimated

Enrollment

16Estimated

Phase

Phase 4

Conditions

Cancer

Interventions

Liposomal paclitaxel
Paclitaxel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2009

Last Update Posted Date

Feb 10, 2009Estimated

Name	Class
Nanjing Sike Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether there is any difference of the pharmacokinetics of two taxane formulations, paclitaxel injection and liposomal paclitaxel in Chinese cancer patients with solid tumors.

Detailed Description

The pharmacokinetics of a new formulation of taxane (liposomal paclitaxel) has never been studied in Chinese cancer patients. This clinical trial is designed to find out the pharmacokinetics of liposomal paclitaxel at the dose of 175mg/m2 and whether it has a different pharmacokinetic profile to paclitaxel.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Liposomal paclitaxel	Drug: Liposomal paclitaxel
B	Active Comparator	Paclitaxel	Drug: Paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liposomal paclitaxel	Drug	Patients will be given Liposomal paclitaxel intravenously in 3 hours with the dose of 175mg/m2 at the first day of chemotherapy. Cycle duration will be 21 days. Each patient will receive 3 cycles of therapy.

Measure	Description	Time Frame
Pharmacokinetic parameters		72 hours after the infusion

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible patients must have histologically confirmed solid tumors of advanced stages
Patients who are suitable for being treated with liposomal paclitaxel only
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Patients who are expected to be alive for at least 3 months
Adequate hematologic, hepatic and renal functions
Adequate other organ functions as defined by the protocol
No prior systemic chemotherapy at least 4 weeks before the recruitment
No previous anaphylactic reaction to hormone.

Exclusion Criteria:

Allergy to any study medication
Serious complication that would compromise the patient's ability to complete the study
Grade ≥1 neuropathy using NCI CTCAE version 3.0 criteria
Pregnancy or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Li, Doctor	Cancer Hospital of Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital of Fudan University		Shanghai	Shanghai Municipality	200032	China
Cancer Hospital of Fudan University

Type	Date	Date Unknown
Release	Apr 14, 2009
Unrelease		Yes
Release	Apr 20, 2009
Reset	Jun 9, 2009

Submission Tracking

Estimated Results First Submitted Date

Apr 14, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 14, 2009		Yes
Apr 20, 2009

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided