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NCT Number: NCT01158079

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

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Virgen del Rocio, Seville, Andalusia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin > 325 mg/day or other platelet inhibitory agents.
  • Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia.
  • Patient has clinically significant cerebrovascular disease.
  • Patient has a seizure disorder not controlled on medication.

Treatment and study plan

ALN-VSP02

Drug

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

Primary outcomes

  1. Collect long term ALN-VSP02 safety data

    Time frame: Throughout the study

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

Secondary outcomes

  1. Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)

    Time frame: Every 2 months

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

  2. Evaluate preliminary evidence of antitumor activity/antiangiogenic activity

    Time frame: Every 3 - 6 months

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

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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