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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Shin je gook, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inje Pusan Paik university hospital

Authority:

Korea: Food and Drug Administration

Study ID:

DOCXN101

NCT ID:

NCT01336582

Start Date:

August 2009

Completion Date:

August 2012

Related Keywords:

  • Solid Tumor
  • suitable candidate
  • single agent docetaxel therapy
  • Advanced Solid Tumor
  • Neoplasms

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