Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
This study has been completed.
Sponsor:
Sunesis Pharmaceuticals
Information provided by:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00246662
First received: June 30, 2005
Last updated: March 10, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to determine the safety and preliminary effectiveness of SNS-595 for the treatment of advanced blood cancers and to learn more about how different doses of SNS-595 affect the disease and the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Acute Leukemia, Nonlymphocytic, Acute Leukemia, Myeloid, Chronic Myelodysplastic Syndromes |
Drug: SNS-595 Injection |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies |
Resource links provided by NLM:
Further study details as provided by Sunesis Pharmaceuticals:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic profile [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Duration of leukemia-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Anti-tumor activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: SNS-595 Injection
All patients receive SNS-595 Injection
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood), biomarker expression, and determining the dose and dose schedule for the next phase of studies with SNS-595.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Able to understand and willing to sign a written informed consent document
- Received less than or equal to 3 induction/re-induction regimens for disease(s) defined by the protocol
- Must have relapsed or refractory leukemia for which no standard therapies are expected to result in a durable remission; patients who have not received prior treatment who have either refused or, in the opinion of the Investigator, are not able to tolerate, standard therapy may be included.
Exclusion Criteria:
- Prior exposure to SNS-595
- Pregnant or breastfeeding
- Women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
- Any evidence of active central nervous system (CNS) leukemia
- Any evidence of acute or chronic graft-versus-host disease
- Has active cancer (other than that which is defined by the inclusion criteria for this protocol), except for skin cancer (excluding melanoma)
- Laboratory values outside normal or reasonable reference range specified by the protocol
- Liver function and kidney function outside limits specified by the protocol
- Not yet recovered from side effects of previous cancer therapy
- Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first SNS-595 dose
- Requires kidney dialysis (hemodialysis or peritoneal)
- Received an investigational agent within 14 days before Cycle 1, Day 1
- Prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (palliative radiation is not excluded as long as it does not exceed greater than or equal to 25% of bone marrow reserve)
- Any other medical (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety or compliance with study procedures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246662
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21231 | |
| United States, New Mexico | |
| New Mexico Cancer Care Alliance | |
| Albuquerque, New Mexico, United States, 87196 | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
| Study Director: | Glenn Michelson, MD | Sunesis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Glenn C. Michelson, MD, Sunesis Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00246662 History of Changes |
| Other Study ID Numbers: | SPO-0004 |
| Study First Received: | June 30, 2005 |
| Last Updated: | March 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunesis Pharmaceuticals:
|
Leukemia Hematologic Blood |
Cancer Malignancy Poor-risk Myelodysplastic Syndromes, including Leukemia, Myelomonocytic (type 2), Chronic |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013