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ALN-VSP02

Phase 1

Solid Tumors | Small molecule | Oncology |Alnylam Pharmaceuticals, Inc.|Last Updated: Oct 12, 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 Trials2
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01158079Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 TreatmentPHASE1 COMPLETED 7Jul 1, 2010Sep 1, 2012Oct 12, 201210 United States, Spain
NCT00882180Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver InvolvementPHASE1 COMPLETED 41Mar 1, 2009Aug 1, 2011Aug 24, 201110 United States, Spain
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Study Endpoints
Primary Endpoints
Collect long term ALN-VSP02 safety data
Throughout the study

Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.

Safety and Tolerability of intravenous ALN-VSP02
up to 16 weeks (4 cycles)
Secondary Endpoints
Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)
Every 2 months
Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
Every 3 - 6 months
Plasma and urine PK of ALN-VSP02
8 weeks (two cycles)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ALN-VSP02DRUGThe dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Patient has completed a previous ALN-VSP02 study, and is deemed to have stable disease or better. 2. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 3. Patient has adequate hematologic, liver, and renal function. Exclusion Criteria: ...

Countries:United StatesSpain
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