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Tykerb

Phase 1

Neoplasms, Breast | Small molecule | Oncology |GSK plc|Last Updated: Aug 31, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment59
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00462956GW572016 In Patients With Advanced Or Metastatic Breast CancerPHASE1 COMPLETED 59 — — Jun 30, 2004Dec 20, 2006Aug 31, 20189 Japan,
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Study Endpoints
Primary Endpoints
To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016
Secondary Endpoints
Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
lapatinib 1500mg dailyEXPERIMENTALSubjects will self-administer lapatinib 1500 mg orally once daily.
Interventions
NameTypeDescription
TykerbDRUGlapatinib 1500mg daily
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Eligibility Criteria
Age Range20 Years — 40 Years
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients. * Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in ...

Countries:Japan
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