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

NCT ID: NCT01336582

Last Updated: 2012-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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

Conditions

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Solid Tumor

Keywords

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suitable candidate single agent docetaxel therapy Advanced Solid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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docetaxel

Group Type EXPERIMENTAL

taxotere

Intervention Type DRUG

70 mg/m2 for age of ≥ 65

Taxotere

Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)

Group Type ACTIVE_COMPARATOR

taxotere

Intervention Type DRUG

70 mg/m2 for age of ≥ 65

Interventions

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taxotere

70 mg/m2 for age of ≥ 65

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shin je gook, doctor

Role: PRINCIPAL_INVESTIGATOR

Inje Pusan Paik university hospital

Locations

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Inje Pusan paik University hospital

Pusan, Jin-Gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DOCXN101

Identifier Type: -

Identifier Source: org_study_id