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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00246662
First Posted: October 31, 2005
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
  Purpose
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.

Condition Intervention Phase
Leukemia, Lymphocytic, Acute Leukemia, Nonlymphocytic, Acute Leukemia, Myeloid, Chronic Myelodysplastic Syndromes Drug: Vosaroxin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 6 months ]
  • Duration of leukemia-free survival [ Time Frame: 6 months ]
  • Anti-tumor activity [ Time Frame: 6 months ]

Enrollment: 75
Study Start Date: November 14, 2005
Study Completion Date: April 2009
Primary Completion Date: December 23, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sch A (18 mg/m2 vosaroxin initially)
Once weekly intravenous on days 1, 8, 15 up to 4 cycles
Drug: Vosaroxin
All patients receive vosaroxin Injection
Other Names:
  • SNS-595
  • Voreloxin
Experimental: Sch B (9 mg/m2 vosaroxin initially)
Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles
Drug: Vosaroxin
All patients receive vosaroxin Injection
Other Names:
  • SNS-595
  • Voreloxin

Detailed Description:
Patients assigned to 1 of 2 schedules (A and B) in cohorts of at least 3 patients received vosaroxin (SNS-595) intravenously (IV) for up to 4 cycles: once weekly (Days 1, 8, 15 in Schedule A) or twice weekly (Days 1, 4, 8, 11 in Schedule B). Dose escalation proceeded independently for Schedule A (18 mg/m2 initially) and Schedule B (9 mg/m2 initially) in the absence of Dose-limiting Toxicity (DLT) based on a modified Fibonacci sequence. The incidence of DLT during Cycle 1 determined the maximum-tolerated dose (MTD) allowing for treatment delays of up to 14 days to resolve clinically significant abnormal laboratory values or related treatment-emergent adverse events (TEAEs) and one dose reduction of 25% in case of above. Patients with stable disease, hematologic improvement, or partial remission with stable blast counts or experiencing clinical benefit in the opinion of the investigator were eligible to receive vosaroxin for up to 4 additional cycles.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Able to understand and willing to sign a written informed consent document
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, 0r 2
  • 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:

  • Prior exposure to SNS-595 (vosaroxin)
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00246662     History of Changes
Other Study ID Numbers: SPO-0004
First Submitted: June 30, 2005
First Posted: October 31, 2005
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data of participants experiencing Adverse Events

Keywords provided by Sunesis Pharmaceuticals:
Leukemia
Hematologic
Blood
Cancer
Malignancy
Myelodysplastic Syndromes

Additional relevant MeSH terms:
Leukemia
Neoplasms
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders