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European Taxotere

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01268163The Pharmacokinetics and Safety Characteristics of Docetaxel in Patients With CancerPHASE1 COMPLETED 32 — — Aug 1, 2007Dec 1, 2008Mar 20, 20174 Russia, United Kingdom
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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 — 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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