Advanced Solid TumorsPhase 1NCT00519662
Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors
A Phase 1 study testing SNS-314 in people with Advanced Solid Tumors, run by Sunesis Pharmaceuticals at 4 sites in United States.
Trial summary
This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SNS-314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2007to Mar 2009
- 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
- Advanced solid tumor and that is measurable by a scan
Who cannot join
- Uncontrolled or untreated central nervous system metastases
- Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
- Any of the following cardiac conditions:
- History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
- Class III or IV heart failure up to 6 months before Cycle 1 Day 1
- Baseline heart rate corrected QT interval (QTc)> 450 msec
Show all 12Show fewer
- History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
- Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
- Previous cancer treatment up to 21 days before first dose
- Any investigational therapy up to 28 days before Cycle 1 Day 1
- Known allergy to cyclodextrins
- Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Duke University
Durham, North Carolina, 27710
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Phase 1 Open-Label Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-314, a Novel Aurora Kinase Inhibitor, Administered to Patients With Advanced Solid Tumors
This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
Read the detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
- Conditions
- Advanced Solid Tumors
- Being tested
- SNS-314
- Keywords
- Solid, Tumors, Advanced
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-314Drug
Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15
Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1
| Study group | Role | What they receive |
|---|---|---|
| Dose escalating cohorts of SNS-314 | Experimental | Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema. Receives: Drug: SNS-314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of SNS-314
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Michelson, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519662
- Sponsor's protocol ID
- SPO-0011
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2007
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of SNS-314, a Novel Aurora Kinase Inhibitor, Administered to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00519662
- Acronym / sponsor ID
- SPO-0011
- Conditions
- Advanced Solid Tumors
- Keywords
- Solid, Tumors, Advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Aug 2007 (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 is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
Detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalating cohorts of SNS-314 | Experimental | Drug: SNS-314Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced solid tumor and that is measurable by a scan
Key exclusion criteria (12 listed)
- Uncontrolled or untreated central nervous system metastases
- Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
- Any of the following cardiac conditions:
- History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
- Class III or IV heart failure up to 6 months before Cycle 1 Day 1
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-314Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15 Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1 | Drug | Dose escalating cohorts of SNS-314 |
Primary outcome
To assess the safety and tolerability of SNS-314
Time frame: 1 Year
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 4 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Glenn Michelson, 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-314 in people with Advanced Solid Tumors, 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 1 inclusion and 12 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 4 Apr 2017. 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.
What does the primary outcome measure?
To assess the safety and tolerability of SNS-314 (time frame: 1 Year). 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 4 Apr 2017.