Clinical trial · Interventional
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
NCT00664170CI-TRIAL-00002334completedPhase 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)
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANX-514 | Drug | — | UNRESOLVED |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- ANX-514
- interventionNames
- Drug: ANX-514
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Taxotere
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
- measure
- Pharmacokinetic equivalence of ANX-514 and Taxotere
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old. * Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment. * ECOG performance status of 0-2 and Karnofsky Score of 100-70. Exclusion Criteria: * Patients who have more effective therapy available than single agent docetaxel for the malignancy. * Pregnancy or lactation. * Intolerance to any antineoplastic agents belonging to the taxoid family. * Hypersensitivity to drugs formulated with polysorbate 80. * Active infection. * Prior anticancer therapy within 30 days prior to the first day of study treatment. * Participation in another experimental drug study within 30 days prior to the first day of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.