TumorsPhase 1NCT00292864
Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors
A Phase 1 study testing SNS-032 Injection in people with Tumors, run by Sunesis Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- SNS-032 Injection
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2006to Dec 2007
- 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
- Able to provide written informed consent
- Advanced, progressing solid tumor that has no cure
- In Stage 1, any advanced solid malignancy
- In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Recovered from radiation therapy that may have been given in the last 21 days
- Recovered from surgery
Who cannot join
- Prior exposure to SNS-032 (previously known as BMS-387032)
- Pregnant or breastfeeding
- Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control
- Took part in another clinical trial during the last 21 days
- Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin
- Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment.
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- Other active malignancies
- Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve
- Any other condition that would keep the patient from safely taking part in the clinical trial
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
University of California Davis Medical Center
Davis, California, 95817
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
About this study
Official title: Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors
The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.
Read the detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.
- Conditions
- Tumors
- Being tested
- SNS-032 Injection
- Keywords
- Cancer, Carcinoma, Adenocarcinoma, Tumor, Advanced solid tumors
- Medical subject headings
- Neoplasms, Carcinoma, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-032 InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Tolerability
Secondary outcomes (4)
Pharmacokinetic profile
Effect on QT interval
Potential biomarkers
Anti-tumor activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel C. Adelman, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292864
- Sponsor's protocol ID
- SPO-0007
- Status last verified
- Jun 2012
- First submitted
- 15 Feb 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
Publications
Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
PubMed 19238148
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of SNS-032, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Select Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00292864
- Acronym / sponsor ID
- SPO-0007
- Conditions
- Tumors
- Keywords
- Cancer, Carcinoma, Adenocarcinoma, Tumor, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Feb 2006 (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 assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.
Detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Able to provide written informed consent
- Advanced, progressing solid tumor that has no cure
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- Recovered from radiation therapy that may have been given in the last 21 days
- Recovered from surgery
Key exclusion criteria (10 listed)
- Prior exposure to SNS-032 (previously known as BMS-387032)
- Pregnant or breastfeeding
- Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control
- Took part in another clinical trial during the last 21 days
- Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin
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-032 Injection | Drug | – |
Primary outcome
Safety
Tolerability
4 secondary outcomes
Pharmacokinetic profile
Effect on QT interval
Potential biomarkers
Anti-tumor activity
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 7 Jun 2012.
- Derived from this study: PubMed 19238148Malumbres M, Barbacid M. Cell cycle, CDKs and cancer: a changing paradigm. Nat Rev Cancer. 2009 Mar;9(3):153-66. doi: 10.1038/nrc2602.
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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
6 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-032 Injection in people with Tumors, run by Sunesis Pharmaceuticals at 6 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 7 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292864, which also lists 1 linked publication.
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 7 Jun 2012.