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

Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01336582

Enrollment

Registered

2011-04-18

Start date

2009-08-31

Completion date

2012-08-31

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Keywords

suitable candidate, single agent docetaxel therapy, Advanced Solid Tumor

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

Interventions

DRUGtaxotere

70 mg/m2 for age of ≥ 65

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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	3 months
Number of paticipants with Adverse Events	3months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026