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TAK-165

Phase 1

Breast Neoplasm | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034281Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2PHASE1 COMPLETED 16Jun 1, 2002Sep 1, 2003Feb 2, 20124 United States
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Maximum Tolerated Dose
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Optimal Dosing for Phase II Studies.
End of Study.
Secondary Endpoints
Clinical Pharmacokinetic Profile of TAK-165
Days 8, 15, 22, 28 and every 14 days thereafter to Final Visit
Response Evaluation Criteria in Solid Tumors Documentation of Objective Tumor Response.
Day 56
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-165 QDEXPERIMENTAL -
Interventions
NameTypeDescription
TAK-165DRUGStarting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Have advanced or metastatic cancer which is refractory to standard therapy or subjects for whom there is no known effective therapy. * Have a histologically or cytologically proven diagnosis of a solid tumor known to express HER2. * Have a predicted life expectancy of greater ...

Countries:United States
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