B-lymphoid MalignanciesPhase 1NCT00446342
Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
A Phase 1 study testing SNS-032 Injection in people with B-lymphoid Malignancies and Chronic Lymphocytic Leukemia, 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 escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
- What is being tested?
- SNS-032 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 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
- Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).
- Evidence of relapsed disease
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Who cannot join
- Prior treatment with SNS-032 injection (previously known as BMS-387032)
- Pregnant or breastfeeding
- Unwilling to use an approved, effective means of contraception according to the study site's standards
- Use of therapeutic anticoagulation agents
- Prior allogeneic bone marrow transplantation
- Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose.
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- Prior pelvic radiation therapy or radiation to > 25% of bone marrow reserve
- Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
- Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
City of Hope
Duarte, California, 91010
Hackensack University Medical Center at the Cancer Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center, University of Texas
Houston, Texas, 77230
Stanford Cancer Center
Stanford, California, 94305
About this study
Official title: Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies
The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.
Read the detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
- Conditions
- B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma
- Being tested
- SNS-032 Injection
- Keywords
- leukemia, lymphoma, myeloma, non-Hodgkin's, CLL, MCL, MM, Phase 1, hematological malignancy
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Multiple Myeloma, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-032 InjectionDrug
Stage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle
Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation of SNS-032 injection | Experimental | Patients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group. Receives: Drug: SNS-032 Injection |
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-032
Measured: 1 year
Secondary outcomes (2)
To characterize the pharmacokinetic profile of SNS-032
Measured: 1 year
Identify a recommended Phase 2 dose and schedule of administration
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 posted12 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionMar 2009
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 B-lymphoid MalignanciesStudies 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
- 21 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
- NCT00446342
- Sponsor's protocol ID
- SPO-0009
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2007
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Multicenter, Dose-Escalation Clinical Study of the Safety and Tolerability of Intravenously Administered SNS-032 Injection, a Novel Cyclin-Dependent Kinase Inhibitor, Administered to Patients With Advanced B-Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00446342
- Acronym / sponsor ID
- SPO-0009
- Conditions
- B-lymphoid Malignancies, Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Multiple Myeloma
- Keywords
- leukemia, lymphoma, myeloma, non-Hodgkin's, CLL, MCL, MM, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Mar 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.
The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.
Detailed description
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation of SNS-032 injection | Experimental | Drug: SNS-032 InjectionPatients escalated to MTD starting in Cohort 1 of 15 mg/m2 of SNS-032 injection, with 1.5-fold increase each cohort and a maximum loading dose increase of 10 mg/m2. Each dose cohort will have a minimum of 3 patients each with advanced CLL or MM. Dose escalation continues in the absence of Cycle 1 DLT criteria until an MTD is achieved for each disease type to a maximum of 7 cohorts at a high dose of 70 mg/m2. Stage 2 tests at MTD in larger group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).
- Evidence of relapsed disease
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Key exclusion criteria (9 listed)
- Prior treatment with SNS-032 injection (previously known as BMS-387032)
- Pregnant or breastfeeding
- Unwilling to use an approved, effective means of contraception according to the study site's standards
- Use of therapeutic anticoagulation agents
- Prior allogeneic bone marrow transplantation
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 InjectionStage 1: Escalating doses of SNS-032 on days 1, 8 and 15 per 28 day cycle Stage 2: Same as stage 1 except SNS-032 administered at the maximum tolerated dose established in stage 1 | Drug | Dose-escalation of SNS-032 injection |
Primary outcome
To assess the safety and tolerability of SNS-032
Time frame: 1 year
2 secondary outcomes
To characterize the pharmacokinetic profile of SNS-032
Time frame: 1 year
Identify a recommended Phase 2 dose and schedule of administration
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 11 Apr 2017.
- 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.
- Individual participant dataSharing planned: No
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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.
Glenn Michelson, 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 B-lymphoid Malignancies and Chronic Lymphocytic Leukemia, 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 4 inclusion and 9 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 11 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 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?
To assess the safety and tolerability of SNS-032 (time frame: 1 year). 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 NCT00446342, 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 11 Apr 2017.