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| Sponsored by: |
Sunesis Pharmaceuticals |
|---|---|
| Information provided by: | Sunesis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00541866 |
Purpose
This study will evaluate the safety and tolerability of SNS-595 Injection in combination with cytarabine in acute myeloid leukemia in humans.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: SNS-595 Injection and cytarabine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Phase 1b/2 Open-Label, Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and PK and PD Profiles of SNS-595 Injection in Combination With Cytarabine in Patients With Relapsed or Refractory AML |
| Estimated Enrollment: | 105 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
All patients entered into 1 arm
|
Drug: SNS-595 Injection and cytarabine
Stage 1 - Escalating doses of SNS-595 on days 1 and 4 in combination with a 5-day continuous IV (in the vein) infusion dose of 400 mg/m2 cytarabine Stage 2 - Same as stage 1 except SNS-595 administered at the maximum tolerated dose established in stage 1 |
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 all study criteria are met.
Contacts and Locations| Contact: Glenn Michelson, MD | 1-877-767-7672 | clinicaltrials@sunesis.com |
| United States, Florida | |
| H. Lee Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Indiana | |
| Indiana University Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46206 | |
| United States, Maryland | |
| Johns Hopkins University - Sidney Kimmel Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| United States, New York | |
| New York Presbyterian Hospital-Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10065 | |
| Study Director: | Craig Berman, MD | Sunesis Pharmaceuticals |
More Information
| Responsible Party: | Sunesis Pharmaceuticals, Inc. ( Glenn Michelson, MD ) |
| Study ID Numbers: | SPO-0012 |
| Study First Received: | October 8, 2007 |
| Last Updated: | December 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00541866 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia Acute Myeloid Relapsed Refractory Cancer |
AML Cytarabine SNS-595 Phase 1 Voreloxin |
|
Leukemia Acute myelogenous leukemia Leukemia, Myeloid |
Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |
