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ALN-VSP02

Phase 1

Solid Tumors | Small molecule | Oncology |Alnylam Pharmaceuticals, Inc.|Last Updated: Oct 12, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ALN-VSP02 · 2 trials · 1 indication

Phase 1 2
NCT01158079Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 TreatmentSolid Tumors
COMPLETED7 Analytics
NCT00882180Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver InvolvementSolid Tumors
COMPLETED41 Analytics
PHASE1COMPLETED
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
Solid TumorsUnlock trial analytics
PHASE1COMPLETED
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about ALN-VSP02

What is ALN-VSP02 used for?

ALN-VSP02 is an investigational drug being developed for the treatment of solid tumors with liver involvement. It is intended for patients with advanced solid tumors, as studied in clinical trials. The drug is administered intravenously and is currently in Phase 1 clinical development.

Who makes ALN-VSP02?

ALN-VSP02 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ALNY. The company has conducted clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALN-VSP02 in patients with advanced solid tumors.

What phase is ALN-VSP02 in?

ALN-VSP02 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 48 patients. The drug is investigational and has not been approved by regulatory authorities. It remains in clinical development for the treatment of solid tumors.

What clinical trials is ALN-VSP02 in?

ALN-VSP02 has been studied in two completed Phase 1 clinical trials. The first trial, NCT00882180, was a dose escalation study in 41 patients with advanced solid tumors with liver involvement. The second trial, NCT01158079, was an extension study in 7 patients who responded to ALN-VSP02 treatment. Both trials were conducted in the United States and Spain.

How is ALN-VSP02 administered?

ALN-VSP02 is administered intravenously, as indicated in the clinical trial protocols. The drug was given to patients with advanced solid tumors with liver involvement in a dose escalation study to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.