Clinical trial · Interventional
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
NCT01158079CI-TRIAL-00008262completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALN-VSP02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Collect long term ALN-VSP02 safety data
- timeFrame
- Throughout the study
- description
- Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
Secondary outcomes (2)
- measure
- Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)
- timeFrame
- Every 2 months
- description
- Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event
- measure
- Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
- timeFrame
- Every 3 - 6 months
- description
- Evaluations will take place every 3-6 months until disease progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin \> 325 mg/day or other platelet inhibitory agents. 2. Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrhythmia. 3. Patient has clinically significant cerebrovascular disease. 4. Patient has a seizure disorder not controlled on medication.
References
Publications (0)
Data not yet available
No reference posted for this study.