NeoplasmsPhase 1NCT00094159
Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors
A Phase 1 study testing SNS-595 in people with Neoplasms, run by Sunesis Pharmaceuticals at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- SNS-595
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Oct 2004to not given
- 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
- Must give written informed consent
- 18 years of age
- Advanced solid malignant tumors
- Tumor can be measured and evaluated
- Blood tests are within standard limits
- Normal blood coagulation
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- ECOG Performance Status equal to 0 or 1
- Hemoglobin > or = to 9.0 g/dL
- Absolute Neutrophil Count > or = to 1,500
- Platelets > or = to 100,000
- Calculated or measured creatinine clearance < 50 mL/min
- Serum creatinine < or = 1.5 times the upper limit of normal (ULN)
- AST, ALT, Alkaline Phosphatase < 3 times ULN except if there is hepatic involvement then AST, ALT, and Alkaline Phosphatase < or = to 5 times ULN
- Total Bilirubin < or = to 2 mg/dL
Who cannot join
- Prior exposure to SNS-595
- Pregnant or breastfeeding.
- Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
- Requires kidney dialysis (hemodialysis or peritoneal).
- Known bleeding disorder (i.e., hemophilia, von Willebrand Disease, coagulopathy, etc.).
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- Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
- Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
- Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
- Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University Medical Center
Durham, North Carolina
Arizona Cancer Center
Scottsdale, Arizona
Stanford University Medical Center
Stanford, California
Arizona Cancer Center
Tucson, Arizona
About this study
Official title: Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies
The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.
Read the detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.
- Conditions
- Neoplasms
- Being tested
- SNS-595
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-595Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel C. Adelman, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094159
- Sponsor's protocol ID
- SPO-0002
- Status last verified
- May 2007
- First submitted
- 14 Oct 2004
- Last updated
- 10 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00094159
- Acronym / sponsor ID
- SPO-0002
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- First posted
- 15 Oct 2004 (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 this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.
Detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.
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 (14 listed)
- Must give written informed consent
- 18 years of age
- Advanced solid malignant tumors
- Tumor can be measured and evaluated
- Blood tests are within standard limits
Key exclusion criteria (10 listed)
- Prior exposure to SNS-595
- Pregnant or breastfeeding.
- Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
- Requires kidney dialysis (hemodialysis or peritoneal).
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 |
|---|---|---|
| SNS-595 | Drug | – |
Primary outcome
Not reported in the source record.
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 10 May 2007.
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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.
Daniel C. Adelman, MD study director
Sunesis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNS-595 in people with Neoplasms, run by Sunesis Pharmaceuticals at 4 sites in United States.
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 14 inclusion and 10 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 10 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
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 10 May 2007.