The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer

NCT01268163 | Completed Phase 1

• 1 other identifier: DOE061
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Cancer

Keywords

Docetaxel; Phase I; Pharmacokinetic; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Area under the concentration time curve from zero to last measured concentration (AUC[0-tlast])

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

• Maximum plasma concentration observed (Cmax)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

Secondary Outcomes (6)

• Area under the concentration time curve from zero to infinity (AUC0-∞)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

• Terminal elimination half life (t1/2)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

• Elimination rate constant (Kel)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

• Total plasma clearance (CL)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

• Volume of distribution (Vss)

  On Day 1, 2, 3, 22, 23, 24, 43, 44, 45 (pre-dose and 30 min, 58 min, 65 min, 70 min, 90 min, 2 hr, 3 hr, 5 hr, 7 hr, 24±2 hr and 48±2 hr after starting Investigational medicinal product infusion during each treatment cycle).

Study Arms (3)

1

ACTIVE COMPARATOR

European Taxotere® (Taxotere EU) 60-100 mg/m\^2

Drug: European Taxotere®

3

EXPERIMENTAL

Hospira Docetaxel Injection 60-100 mg/m\^2

Drug: Hospira Docetaxel Injection

2

ACTIVE COMPARATOR

American Taxotere® (Taxotere US) 60-100 mg/m\^2

Drug: American Taxotere®

Interventions

European Taxotere® DRUG

60-100 mg/m\^2 IV

1

American Taxotere® DRUG

60-100 mg/m\^2 IV

2

Hospira Docetaxel Injection DRUG

60-100 mg/m\^2 IV

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (4)

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Cambridge, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• M. Ranson

  Christie Hospital, Manchester

  PRINCIPAL INVESTIGATOR

• V Semiglazov

  N.N. Petrov Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: December 29, 2010
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 20, 2017

Record last verified: 2015-07

Locations

GB (3); RU (1)