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

This study has been completed.
Sponsor:
Information provided by:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00246662
First received: June 30, 2005
Last updated: March 10, 2011
Last verified: March 2011
  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:
    Drug: SNS-595 Injection
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Hematologic Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 July 10, 2014