Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer
This study has been completed.
Sponsor:
Samyang Biopharmaceuticals Corporation
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01336582
First received: March 21, 2011
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor |
Drug: taxotere |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor |
Resource links provided by NLM:
Further study details as provided by Samyang Biopharmaceuticals Corporation:
Primary Outcome Measures:
- Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Pharmacokinetics of the CL of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Pharmacokinetics of the Vdss of SYP-0704A and Taxotere [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of paticipants with Adverse Events [ Time Frame: 3months ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: docetaxel |
Drug: taxotere
70 mg/m2 for age of ≥ 65
|
|
Active Comparator: Taxotere
Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)
|
Drug: taxotere
70 mg/m2 for age of ≥ 65
|
Detailed Description:
Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336582
Locations
| Korea, Republic of | |
| Inje Pusan paik University hospital | |
| Pusan, Jin-Gu, Korea, Republic of, 614-735 | |
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
Investigators
| Principal Investigator: | Shin je gook, doctor | Inje Pusan Paik university hospital |
More Information
No publications provided
| Responsible Party: | Samyang Biopharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT01336582 History of Changes |
| Other Study ID Numbers: | DOCXN101 |
| Study First Received: | March 21, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Samyang Biopharmaceuticals Corporation:
|
suitable candidate single agent docetaxel therapy Advanced Solid Tumor |
Additional relevant MeSH terms:
|
Neoplasms Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013