Trials / Completed
CompletedNCT00246662
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Sunesis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Leukemia, Lymphocytic, Acute
- Leukemia, Nonlymphocytic, Acute
- Leukemia, Myeloid, Chronic
- Myelodysplastic Syndromes
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vosaroxin | All patients receive vosaroxin Injection |
Timeline
- Start date
- 2005-11-14
- Primary completion
- 2008-12-23
- Completion
- 2009-04-01
- First posted
- 2005-10-31
- Last updated
- 2017-03-30
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00246662. Inclusion in this directory is not an endorsement.