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

NCT01336582 | Completed Phase 1

• 1 other identifier: DOCXN101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

suitable candidate; single agent docetaxel therapy; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC

  3 months

Secondary Outcomes (4)

• 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

Study Arms (2)

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

taxotere DRUG

70 mg/m2 for age of ≥ 65

Taxotere; docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Inje Pusan paik University hospital

Pusan, Jin-Gu, 614-735, South Korea

Location

MeSH Terms

Interventions

Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Shin je gook, doctor

  Inje Pusan Paik university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: April 18, 2011
• Study Start: August 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

KR (1)