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ALN-VSP02

Akshay Vaishnaw, MD PhD

The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.

Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

A Multi-Center, Open Label, Phase 1 Dose-Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 in Patients With Advanced Solid Tumors With Liver Involvement

Alnylam Pharmaceuticals

The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study

This study provides a mechanism for continued administration of ALN-VSP02 therapy to patients with cancer who completed participation in another ALN-VSP02 clinical study. The primary objective of this study is to collect long term safety data.

Study ALN-VSP02 is an extension study for previously conducted ALN-VSP02 studies. The study is being conducted to allow for continued ALN-VSP02 therapy for patients who completed participation in an ALN-VSP02 clinical study, achieved clinical benefit with ALN-VSP02 (i.e., disease response of stable disease or better), and, in the Investigator's opinion, may benefit from continuation of ALN-VSP02 therapy.

Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment

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

Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event

Evaluations will take place every 3-6 months until disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement	NCT00882180	Solid Tumors	ALN-VSP02	18 Years -	Alnylam Pharmaceuticals
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment	NCT01158079	Solid Tumors	ALN-VSP02	18 Years -	Alnylam Pharmaceuticals
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment	NCT01158079	Solid Tumors	ALN-VSP02	18 Years -	Alnylam Pharmaceuticals

Spots Global Cancer Trial Database for advanced solid tumors with liver involvement