Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies
NCT ID: NCT00446342
Last Updated: 2017-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2007-02-28
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose-escalation of SNS-032 injection
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.
SNS-032 Injection
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
Interventions
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SNS-032 Injection
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
Eligibility Criteria
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Inclusion Criteria
* Evidence of relapsed disease
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Sunesis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Glenn Michelson, MD
Role: STUDY_DIRECTOR
Sunesis Pharmaceuticals
Locations
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City of Hope
Duarte, California, United States
Stanford Cancer Center
Stanford, California, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Hackensack University Medical Center at the Cancer Center
Hackensack, New Jersey, United States
MD Anderson Cancer Center, University of Texas
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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SPO-0009
Identifier Type: -
Identifier Source: org_study_id
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