Clinical trial · Interventional
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
NCT01336582CI-TRIAL-00008732completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| taxotere | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- docetaxel
- interventionNames
- Drug: taxotere
- type
- ACTIVE_COMPARATOR
- label
- Taxotere
- description
- Docetaxel-PM 75 mg/m2 (70 mg/m2 for age of ≥ 65) Taxotere 75mg/m2 (70 mg/m2 for age of ≥ 65)
- interventionNames
- Drug: taxotere
Primary outcomes (1)
- measure
- Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC
- timeFrame
- 3 months
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.