Clinical trial NCT00607997: Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Official title: A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Acute Disease
Acute Myeloid Leukemia
Nonlymphocytic Leukemia
Myelodysplastic Syndromes
Keywords: Leukemia
Myeloid
Elderly
Hematologic
Blood
Cancer
Malignancy
SNS-595
Sunesis
Hematologic Diseases
Myelodysplastic Syndromes
Older
voreloxin
reveal-1
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 113
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Detailed description: Other objectives of this study include:

1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Eligibility criteria: Key Inclusion Criteria:

1. At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
2. At least 20% blasts by BM biopsy or aspirate
3. ECOG performance status of 0,1,or 2
4. Adequate cardiac, renal and liver function

Key Exclusion Criteria:

1. Uncontrolled DIC
2. Active central nervous system involvement by AML
3. Requiring hemodialysis or peritoneal dialysis
4. Some prior history of heart attack or stroke (depending on how long ago the event occurred)

Primary outcomes:
measure: Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
timeFrame: 2 years
Secondary outcomes:
measure: Leukemia-free Survival (LFS)
timeFrame: 2 years
measure: Overall Survival
timeFrame: 2 years
measure: Pharmacokinetics Day 1 - Cmax (ng/mL)
timeFrame: 1 Day
measure: Pharmacokinetics Day 4 Cmax (ng/mL)
timeFrame: Day 4
measure: All Cause Mortality
timeFrame: 30 and 60 days
measure: Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
timeFrame: 1 Day
measure: Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
timeFrame: 1 Day
measure: Pharmacokinetics Day 1 - CL (L/hr)
timeFrame: 1 Day
measure: Pharmacokinetics Day 1 - Vss (L)
timeFrame: 1 Day
measure: Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
timeFrame: Day 4
measure: Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
timeFrame: Day 4
measure: Pharmacokinetics Day 4 - CL (L/hr)
timeFrame: Day 4
measure: Pharmacokinetics Day 4 - Vss (L)
timeFrame: Day 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Blood and Marrow Transplant Program
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Francis Hospital & Health Systems at Beech Grove Campus
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Shreveport
country: United States
facility: LSU Health Sciences Center at Shreveport
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: University of MO Ellis Fischel Cancer Center
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Adam Craig, MD
role: STUDY_DIRECTOR
References:
citation: Stuart RK, Cripe LD, Maris MB, Cooper MA, Stone RM, Dakhil SR, Turturro F, Stock W, Mason J, Shami PJ, Strickland SA, Costa LJ, Borthakur G, Michelson GC, Fox JA, Leavitt RD, Ravandi F. REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukaemia. Br J Haematol. 2015 Mar;168(6):796-805. doi: 10.1111/bjh.13214. Epub 2014 Nov 17.