CancerPhase 1NCT01268163
The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer
A Phase 1 study testing European Taxotere®, American Taxotere® and Hospira Docetaxel Injection in people with Cancer, run by Hospira, now a wholly owned subsidiary of Pfizer at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- European Taxotere®, American Taxotere® and Hospira Docetaxel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Study site
Cambridge
Study site
Glasgow
Study site
Manchester
About this study
Official title: 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.
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.
Read the detailed description
No information is available on the pharmacokinetic characteristics, safety or efficacy of Hospira Docetaxel Injection. The primary purpose of this study therefore is to compare the pharmacokinetic characteristics of 60-100 mg/m² Hospira Docetaxel Injection, 60-100 mg/m² European Taxotere® (Taxotere® EU) and 60-100 mg/m² American Taxotere® (Taxotere® US) when administered as a 1 hour intravenous infusion in man. The secondary objective of this study will be to compare the safety and tolerability of Hospira Docetaxel Injection, Taxotere® EU and Taxotere® US. The study will also provide an opportunity to assess selected efficacy endpoints according to local practice after each cycle of treatment.
The study dosing regimen (60-100 mg/m², administered as a 1 hour intravenous infusion at 3 week intervals) and subject population (cancer patients for whom Taxotere® monotherapy would be a suitable treatment option) were selected on the basis of the licensed use of 60-100 mg/m² Taxotere®. The randomised crossover design was chosen to reduce the effect of intersubject variation.
Since Hospira Docetaxel Injection has not been administered to man there is no information on the risks associated with its clinical use. However the active ingredient of Hospira Docetaxel Injection is the same as that of Taxotere® and it is expected that Hospira Docetaxel Injection will exhibit a similar safety and tolerability profile.
An estimated 24 patients will be recruited at several United Kingdom sites and one Russian site to provide 19 evaluable patients
- Conditions
- Cancer
- Being tested
- European Taxotere®, American Taxotere®, Hospira Docetaxel Injection
- Keywords
- Docetaxel, Phase I, Pharmacokinetic, Bioequivalence
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Taxotere®Drug
60-100 mg/m^2 IV
American Taxotere®Drug
60-100 mg/m^2 IV
Hospira Docetaxel InjectionDrug
60-100 mg/m^2 IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | European Taxotere® (Taxotere EU) 60-100 mg/m^2 Receives: Drug: European Taxotere® |
| 3 | Experimental | Hospira Docetaxel Injection 60-100 mg/m^2 Receives: Drug: Hospira Docetaxel Injection |
| 2 | Active comparator | American Taxotere® (Taxotere US) 60-100 mg/m^2 Receives: Drug: American Taxotere® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from zero to last measured concentration (AUC[0-tlast])
Measured: 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)
Measured: 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-∞)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Area under the concentration time curve for unbound docetaxel
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startAug 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Ranson, Principal investigator, Christie Hospital, ManchesterV Semiglazov, Principal investigator, N.N. Petrov Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268163
- Sponsor's protocol ID
- DOE061
- Status last verified
- Jul 2015
- First submitted
- 8 Oct 2010
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01268163
- Acronym / sponsor ID
- DOE061
- Conditions
- Cancer
- Keywords
- Docetaxel, Phase I, Pharmacokinetic, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
No information is available on the pharmacokinetic characteristics, safety or efficacy of Hospira Docetaxel Injection. The primary purpose of this study therefore is to compare the pharmacokinetic characteristics of 60-100 mg/m² Hospira Docetaxel Injection, 60-100 mg/m² European Taxotere® (Taxotere® EU) and 60-100 mg/m² American Taxotere® (Taxotere® US) when administered as a 1 hour intravenous infusion in man. The secondary objective of this study will be to compare the safety and tolerability of Hospira Docetaxel Injection, Taxotere® EU and Taxotere® US. The study will also provide an opportunity to assess selected efficacy endpoints according to local practice after each cycle of treatment.
The study dosing regimen (60-100 mg/m², administered as a 1 hour intravenous infusion at 3 week intervals) and subject population (cancer patients for whom Taxotere® monotherapy would be a suitable treatment option) were selected on the basis of the licensed use of 60-100 mg/m² Taxotere®. The randomised crossover design was chosen to reduce the effect of intersubject variation.
Since Hospira Docetaxel Injection has not been administered to man there is no information on the risks associated with its clinical use. However the active ingredient of Hospira Docetaxel Injection is the same as that of Taxotere® and it is expected that Hospira Docetaxel Injection will exhibit a similar safety and tolerability profile.
An estimated 24 patients will be recruited at several United Kingdom sites and one Russian site to provide 19 evaluable patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: European Taxotere®European Taxotere® (Taxotere EU) 60-100 mg/m^2 |
| 3 | Experimental | Drug: Hospira Docetaxel InjectionHospira Docetaxel Injection 60-100 mg/m^2 |
| 2 | Active comparator | Drug: American Taxotere®American Taxotere® (Taxotere US) 60-100 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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):
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| European Taxotere®60-100 mg/m^2 IV | Drug | 1 |
| American Taxotere®60-100 mg/m^2 IV | Drug | 2 |
| Hospira Docetaxel Injection60-100 mg/m^2 IV | Drug | 3 |
Primary outcome
Area under the concentration time curve from zero to last measured concentration (AUC[0-tlast])
Time frame: 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)
Time frame: 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).
6 secondary outcomes
Area under the concentration time curve from zero to infinity (AUC0-∞)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Area under the concentration time curve for unbound docetaxel
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Ranson principal investigator
Christie Hospital, Manchester
V Semiglazov principal investigator
N.N. Petrov Research Institute of Oncology
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing European Taxotere®, American Taxotere® and Hospira Docetaxel Injection in people with Cancer, run by Hospira, now a wholly owned subsidiary of Pfizer at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve from zero to last measured concentration (AUC[0-tlast]) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.