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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.
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNS-032 Injection | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of SNS-032 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetic profile of SNS-032 | 1 year | |
| Identify a recommended Phase 2 dose and schedule of administration | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Michelson, MD | Sunesis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Stanford Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19238148 | Derived | 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. |
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| Stanford |
| California |
| 94305 |
| United States |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | United States |
| Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Hackensack University Medical Center at the Cancer Center | Hackensack | New Jersey | 07601 | United States |
| MD Anderson Cancer Center, University of Texas | Houston | Texas | 77230 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C484864 | N-(5-(((5-(1,1-dimethylethyl)-2-oxazolyl)methyl)thio)-2-thiazolyl)-4-piperidinecarboxamide |
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