Solid TumorsPhase 1NCT00882180
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 Phase 1 study testing ALN-VSP02 in people with Solid Tumors, run by Alnylam Pharmaceuticals at 10 sites in 2 countries.
Trial summary
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. 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
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2009to Aug 2011
- 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
- Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
- Patient has measurable tumor in the liver
- At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Patient has adequate hematologic, liver, and renal function
- Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Patient has a life expectancy > 12 weeks
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 arrythmia
- Patient has known active brain or leptomeningeal metastases
- Patient has clinically significant cerebrovascular disease
- Patient has a seizure disorder not controlled on medication
- Patient has a known or suspected viral, parasitic or fungal infection
- Patient previously experienced a severe reaction to a liposomal product
- Patient has a known hypersensitivity to lipid products
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, 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
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.
- 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
IV infusion administered every two weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of intravenous ALN-VSP02
Measured: up to 16 weeks (4 cycles)
Secondary outcomes (2)
Plasma and urine PK of ALN-VSP02
Measured: 8 weeks (two cycles)
Assess preliminary evidence of antitumor/antiangiogenic activity
Measured: Up to 16 weeks (4 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2011
- Study completionAug 2011
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT00882180
- Sponsor's protocol ID
- ALN-VSP02-001
- Status last verified
- Aug 2011
- First submitted
- 15 Apr 2009
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00882180
- Acronym / sponsor ID
- ALN-VSP02-001
- Conditions
- Solid Tumors
- Keywords
- Liver, Solid Tumors, Advanced Solid Tumors with Liver Involvement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Apr 2009 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (7 listed)
- Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
- Patient has measurable tumor in the liver
- At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery
- 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 (8 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 arrythmia
- Patient has known active brain or leptomeningeal metastases
- 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-VSP02IV infusion administered every two weeks | Drug | – |
Primary outcome
Safety and Tolerability of intravenous ALN-VSP02
Time frame: up to 16 weeks (4 cycles)
2 secondary outcomes
Plasma and urine PK of ALN-VSP02
Time frame: 8 weeks (two cycles)
Assess preliminary evidence of antitumor/antiangiogenic activity
Time frame: Up to 16 weeks (4 cycles)
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 24 Aug 2011.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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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 7 inclusion and 8 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 24 Aug 2011. 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?
Safety and Tolerability of intravenous ALN-VSP02 (time frame: up to 16 weeks (4 cycles)). 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 24 Aug 2011.