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European Taxotere

Phase 1

Cancer | Small molecule | Oncology |Pfizer, Inc.|Trials Updated: Mar 20, 2017

European Taxotere development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

European Taxotere clinical trials

European Taxotere · 1 trial · 1 indication

Phase 1 1
NCT01268163The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With CancerCancer
COMPLETED32 Analytics
PHASE1COMPLETED
The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer
Cancer
NCT0126816332
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Study Endpoints

Primary Endpoints

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 Endpoints

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).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOREuropean Taxotere® (Taxotere EU) 60-100 mg/m\^2
3EXPERIMENTALHospira Docetaxel Injection 60-100 mg/m\^2
2ACTIVE_COMPARATORAmerican Taxotere® (Taxotere US) 60-100 mg/m\^2

Interventions

NameTypeDescription
European Taxotere®DRUG60-100 mg/m\^2 IV
American Taxotere®DRUG60-100 mg/m\^2 IV
Hospira Docetaxel InjectionDRUG60-100 mg/m\^2 IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 chemi...

Countries:RussiaUnited Kingdom
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Competitive Landscape -Cancer 7 trials

Top 2 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/GEH200521
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about European Taxotere

What is European Taxotere?

European Taxotere is a small molecule oncology drug developed by Pfizer, Inc. (ticker: PFE) for the treatment of cancer. It is also known as European Taxotere®. It is an investigational therapy that has been studied in a Phase 1 clinical trial.

What is European Taxotere used for?

European Taxotere is used for the treatment of cancer. It is an oncology therapy developed by Pfizer, Inc. (ticker: PFE). The drug has been evaluated in a Phase 1 clinical trial in patients with cancer.

Who makes European Taxotere?

European Taxotere is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer of the drug, which is a small molecule oncology therapy.

What phase is European Taxotere in?

European Taxotere is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed.

What clinical trials is European Taxotere in?

European Taxotere has been studied in one clinical trial: NCT01268163, titled "The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With Cancer." This Phase 1 trial was completed and enrolled 32 patients with cancer in Russia and the United Kingdom.

Is European Taxotere the same as European Taxotere®?

Yes, European Taxotere and European Taxotere® refer to the same drug. European Taxotere® is the registered name for the small molecule oncology therapy developed by Pfizer, Inc. (ticker: PFE).

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