Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies - Full Text View

Sponsored by:	Sunesis Pharmaceuticals
Information provided by:	Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00246662

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

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
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

All patients receive SNS-595 Injection

Detailed Description:

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:	Sunesis Pharmaceuticals, Inc. ( Glenn C. Michelson, MD )
Study ID Numbers:	SPO-0004
Study First Received:	June 30, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00246662 History of Changes
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

Study placed in the following topic categories:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Precancerous Conditions
Hematologic Neoplasms
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Disease
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Precancerous Conditions
Immune System Diseases
Hematologic Neoplasms
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia, Myeloid

Leukemia, Myeloid, Acute
Lymphatic Diseases
Leukemia
Preleukemia
Neoplasms
Neoplasms by Site
Pathologic Processes
Syndrome
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 10, 2009