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

NCT00246662 | Completed Phase 1

• 1 other identifier: SPO-0004
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Leukemia, Lymphocytic, Acute; Leukemia, Nonlymphocytic, Acute; Leukemia, Myeloid, Chronic; Myelodysplastic Syndromes

Keywords

Leukemia; Hematologic; Blood; Cancer; Malignancy; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  6 months

Secondary Outcomes (3)

• Pharmacokinetic profile

  6 months

• Duration of leukemia-free survival

  6 months

• Anti-tumor activity

  6 months

Study Arms (2)

Sch A (18 mg/m2 vosaroxin initially)

EXPERIMENTAL

Once weekly intravenous on days 1, 8, 15 up to 4 cycles

Drug: Vosaroxin

Sch B (9 mg/m2 vosaroxin initially)

EXPERIMENTAL

Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles

Drug: Vosaroxin

Interventions

Vosaroxin DRUG

All patients receive vosaroxin Injection

Also known as: SNS-595, Voreloxin

Sch A (18 mg/m2 vosaroxin initially); Sch B (9 mg/m2 vosaroxin initially)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sunesis Pharmaceuticals: lead

Study Sites (5)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87196, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Leukemia; Neoplasms

Interventions

vosaroxin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenn Michelson, MD

  Sunesis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: October 31, 2005
• Study Start: November 14, 2005
• Primary Completion: December 23, 2008
• Study Completion: April 1, 2009
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)