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Taxotere

Phase 3

Breast Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jul 19, 2012

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment616
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00393939Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast CancerPHASE3 COMPLETED 594 — — Feb 1, 2007Jul 1, 2011Jul 19, 2012144 United States, Argentina +25
NCT00291577Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast CancerPHASE1 COMPLETED 22 — — Jul 1, 2006Feb 1, 2009Dec 23, 20093 Belgium, Italy +1
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS)
Baseline up to Month 33

PFS defined as time from date of randomization to date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.4.

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
1, 2, 4, 6, 8, 12, 24 hours postdose

Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.

Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
1, 2, 4, 6, 8, 12, 24 hours postdose

Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).

Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
1, 2, 4, 6, 8, 12, 24 hours postdose

Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).

Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
1, 2, 4, 6, 8, 12, 24 hours postdose

Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters.

Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
0 hour postdose

Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.

Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.

Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).

Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.

Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.

Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean AUC24\_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.

Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.

Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.

Secondary Endpoints
Percentage of Participants With Objective Response
Baseline up to Month 33
Duration of Response (DR)
Baseline up to Month 33
Overall Survival (OS)
Baseline to date of death from any cause (up to Month 33)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BACTIVE_COMPARATOR -
1EXPERIMENTAL -
Interventions
NameTypeDescription
Sunitinib malateDRUGSunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel)
TaxotereDRUGDocetaxel 100 mg/m2 every 3 weeks in the comparator arm
Sunitinib (Sutent)DRUGSunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites144

Inclusion Criteria: * Breast cancer with evidence of unresectable locally recurrent, or metastatic disease * Her-2 negative tumors Exclusion Criteria: * Patients for whom docetaxel is contraindicated * Clinical presentation of inflammatory carcinoma with no other measurable disease

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaColombiaCzechiaFinlandFranceGermanyHungaryIrelandItalyNetherlandsPanamaPolandPortugalRomaniaRussiaSlovakiaSouth KoreaSpainSwedenTurkey (Türkiye)UkraineUnited Kingdom
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