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European Taxotere

Phase 1

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

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

Clinical trial landscape

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 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about European Taxotere

What is European Taxotere used for?

European Taxotere is an investigational small molecule being developed for the treatment of cancer. It is currently in Phase 1 clinical development. The drug is being studied in patients with cancer to evaluate its pharmacokinetics and safety characteristics.

Who makes European Taxotere?

European Taxotere is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research on this drug for the treatment of cancer.

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 regulatory authorities. One Phase 1 clinical trial has been completed to assess its safety and pharmacokinetics in cancer patients.

What clinical trials is European Taxotere in?

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

Is European Taxotere the same as docetaxel?

European Taxotere is a name used for docetaxel in the context of a clinical trial. The study NCT01268163 evaluates the pharmacokinetics and safety of docetaxel in patients with cancer, indicating that European Taxotere refers to this chemotherapy agent.