Pharmacokinetic Study of SYP-0704A and Taxotere to Treat... | NCT01336582

Studies
Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer

NCT01336582

Sponsor

Samyang Biopharmaceuticals Corporation

Status

Completed

Last Update Posted

Dec 21, 2012Estimated

Enrollment

42Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

taxotere

Countries

South Korea

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

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

Aug 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 21, 2011

First Submission Date that Met QC Criteria

Apr 14, 2011

First Posted Date

Apr 18, 2011Estimated

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

Dec 19, 2012

Last Update Posted Date

Dec 21, 2012Estimated

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

Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.

Detailed Description

Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
docetaxel	Experimental		Drug: taxotere
Taxotere	Active Comparator	Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)	Drug: taxotere

Interventions

Name	Type	Description	Arm Group Labels	Other Names
taxotere	Drug	70 mg/m2 for age of ≥ 65	Taxotere docetaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC		3 months

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere		3 months
Pharmacokinetics of the CL of SYP-0704A and Taxotere		3 months
Pharmacokinetics of the Vdss of SYP-0704A and Taxotere

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who aged 18 years or older.
Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
Subjects who have histologically or cytologically confirmed advanced solid tumor.
Subjects who are a suitable candidate for single agent docetaxel therapy for their advanced solid tumors that have failed to standard therapy.
Subjects who have fully recovered from reversible toxic effects of prior therapy. The prior chemotherapy, immunotherapy, hormone therapy, surgery, and/or radiotherapy should be completed at least 21 days before the first administration of investigational product.

Exclusion Criteria:

Subjects who have had a major surgery other than tumor ablation within 2 weeks prior to the screening/baseline visit.
Subjects who have a history of metastasis or currently have a metastasis to the central nervous system (CNS).
Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 2 based on NCI CTCAE V3.0.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shin je gook, doctor	Inje Pusan Paik university hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje Pusan paik University hospital		Pusan	Jin-Gu	614-735	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077143	Docetaxel

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided