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LFA102

Phase 1

Castration-resistant Prostate Cancer, Advanced Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Nov 11, 2014

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01610050A Phase I Study of LFA102 in Japanese PatientsPHASE1 COMPLETED 14 — — Jun 1, 2012Feb 1, 2014Nov 11, 20143 Japan
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicities (DLT)
1st treatment cycle (28 days)

Frequency and severity of dose limiting toxicities (DLTs)

Secondary Endpoints
Frequency, duration and severity of Adverse Events (AEs)
at informed consent, until 28 days after treatment discontinuation
Serum Concentration
cycle 1 day 1 until disease progression
Objective Response Rate
every 8 week or 12 weeks, until disase progression
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LFA102EXPERIMENTAL -
Interventions
NameTypeDescription
LFA102DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * Histologically or cytologically confirmed locally advanced or metastatic breast cancer Exclusion Criteria: * Patients with untreated and/or symptomatic metastatic CNS disease * Prior anaphylactic or other severe infusio...

Countries:Japan
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