Clinical trial · Interventional
The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer
A Phase 1, Double-blinded, Randomised, Multi-centre, Three-period, Three-treatment, Crossover Study to Compare the Intravenous Pharmacokinetic and Safety Characteristics of European Taxotere® and American Taxotere® With Hospira Docetaxel Injection Administered at a Therapeutic Dose in Cancer Patients.
- 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 the pharmacokinetic and safety characteristics of European Taxotere® and American Taxotere® with Hospira Docetaxel injection in patients with 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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| American Taxotere® | Drug | — | UNRESOLVED |
| European Taxotere® | Drug | — | UNRESOLVED |
| Hospira Docetaxel Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- European Taxotere® (Taxotere EU) 60-100 mg/m\^2
- interventionNames
- Drug: European Taxotere®
- type
- EXPERIMENTAL
- label
- 3
- description
- Hospira Docetaxel Injection 60-100 mg/m\^2
- interventionNames
- Drug: Hospira Docetaxel Injection
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- American Taxotere® (Taxotere US) 60-100 mg/m\^2
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent given; * Have medically documented cancer for which Taxotere® monotherapy would be a suitable treatment option; * Aged ≥18 years; * Eastern Cooperative Oncology Group (ECOG) performance status between 0 - 1 (inclusive); * Haematological and serum chemical parameters that comply with the following criteria (based on local laboratory normal reference range): * Haemoglobin ≥9.5 g/dL * Leukocytes ≥3.0 x 10\^9/L * Neutrophils ≥1.5 x 10\^9/L * Platelets ≥100 x 10\^9 L * Total bilirubin ≤2.0 x Upper Limit of Normal (ULN) * Aspartate aminotransferase (AST) ≤2.5 x ULN * Alanine aminotransferase (ALT) ≤2.5 x ULN * Alkaline phosphatase ≤4.0 x ULN * Serum creatinine ≤1.5 x ULN * Willing to use an effective method of contraception, i.e. intrauterine device (IUD), oral contraceptive, subdermal implant or double barrier (condom with a contraceptive sponge or contraceptive suppository), unless anatomically sterile, from screening until at least 12 weeks after last dose of Investigational Medicinal Product. * Willing and able to comply with the requirements of the protocol and available for the planned duration of the study. Exclusion Criteria: * Concomitant treatment with any other cytotoxic agent; * Concomitant use of compounds that induce, inhibit or are metabolized by cytochrome P450, e.g. ciclosporin, ketoconazole, erythromycin, St John's Wort; * History or presence of any clinically significant findings that, in the opinion of the Investigator, would preclude inclusion in the study; * Clinically significant vital signs or 12-lead electrocardiogram (ECG) results, as judged by the Investigator; * Participation in any other clinical trial using an Investigational Medicinal Product within the previous month * History of Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus; * Recent or clinically significant history of drug or alcohol abuse; * Insulin-dependent or unstable Diabetes Mellitus; * History of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with Polysorbate 80; * History of reaction to any drug containing polyethylene glycol 300 (PEG 300); * Pregnancy or lactation.
References
Publications (0)
Data not yet available