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Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies

Phase 1
18 Years
Not Enrolling
Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes

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Trial Information

Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Glenn Michelson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

April 2009

Related Keywords:

  • Leukemia, Lymphocytic, Acute
  • Leukemia, Nonlymphocytic, Acute
  • Leukemia, Myeloid, Chronic
  • Myelodysplastic Syndromes
  • Leukemia
  • Hematologic
  • Blood
  • Cancer
  • Malignancy
  • Poor-risk Myelodysplastic Syndromes, including Leukemia, Myelomonocytic (type 2), Chronic
  • 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



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Johns Hopkins Hospital Baltimore, Maryland  21287
New Mexico Cancer Care Alliance Albuquerque, New Mexico  87106