Solid TumorsPhase 1NCT01158079
Multi-center, Open Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
A Phase 1 study testing ALN-VSP02 in people with Solid Tumors, run by Alnylam Pharmaceuticals at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ALN-VSP02
- How many people
- 7 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2010to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Karmanos Cancer Center
Detroit, Michigan, 48201
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
TGen Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, 85258
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 08035
Hospital Virgen del Rocio
Seville, Andalusia, 41013
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
About this study
Official title: A 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.
Read the detailed description
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.
- Conditions
- Solid Tumors
- Being tested
- ALN-VSP02
- Keywords
- Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-VSP02Drug
The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect long term ALN-VSP02 safety data
Patients remain on treatment until disease progression or an adverse event. Adverse events are assessed throughout treatment.
Measured: Throughout the study
Secondary outcomes (2)
Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)
Disease response is assessed every 2 months until the patient stops treatment due to disease progression or an adverse event
Measured: Every 2 months
Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
Evaluations will take place every 3-6 months until disease progression
Measured: Every 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akshay Vaishnaw, MD PhD, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158079
- Sponsor's protocol ID
- ALN-VSP02-002
- Status last verified
- Oct 2012
- First submitted
- 11 Dec 2009
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-Label, Extension Study of ALN-VSP02 in Cancer Patients Who Have Responded to ALN-VSP02 Treatment
- ClinicalTrials.gov ID
- NCT01158079
- Acronym / sponsor ID
- ALN-VSP02-002
- Conditions
- Solid Tumors
- Keywords
- Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-VSP02The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study | Drug | – |
Primary outcome
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.
2 secondary outcomes
Assess disease response by Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: Every 2 months
Evaluate preliminary evidence of antitumor activity/antiangiogenic activity
Time frame: Every 3 - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshay Vaishnaw, MD PhD study director
Alnylam Pharmaceuticals
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALN-VSP02 in people with Solid Tumors, run by Alnylam Pharmaceuticals at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect long term ALN-VSP02 safety data (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.