A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664170

Enrollment

Registered

2008-04-22

Start date

2008-04-30

Completion date

2009-04-30

Last updated

2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Brief summary

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Interventions

DRUGdocetaxel

75 mg/m\^2

DRUGANX-514

75 mg/m\^2

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic equivalence of ANX-514 and Taxotere	—

Countries

Argentina, Estonia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026