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A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Acute Myeloid Leukemia, Acute Nonlymphocytic Leukemia

Thank you

Trial Information

A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)


Other objectives of this study include comparing the following between treatment groups:

Complete remission (CR) rate

Safety and tolerability

Combined CR rate, defined as CR+CRp+CRi

Overall remission (OR) rate

Event-free survival (EFS)

Durability of remission (CR and combined CR) assessed by leukemia-free survival (LFS)

Percentage of patients who have post-treatment transplantation


Inclusion Criteria:



- Provide signed, written informed consent

- Are at least 18 years of age

- Have a diagnosis of AML according to World Health Organization (WHO) classification

- First relapsed or refractory AML (refractory to initial induction therapy)

- Have an ECOG score of 0-2

- Have adequate liver and renal function as indicated by certain laboratory values

- Are nonfertile or agree to use an adequate method of contraception until 30 days
after the last treatment

Exclusion Criteria:

- Have received more than 2 cycles of induction therapy for AML

- Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or
HIDAC-containing regimen

- Have received a hematopoietic stem cell transplant (HSCT) within the previous 3
months

- Have received active immunosuppressive therapy for graft-versus-host disease (GVHD)
within 2 weeks before study start

- Have any other severe concurrent disease, or have a history of serious disease
involving the heart, kidney, liver, or other organ system

- Have evidence of central nervous system involvement of active AML

- Have other active malignancies (including other hematologic malignancies) or been
diagnosed with other malignancies within the last 12 months, except nonmelanoma skin
cancer or cervical intraepithelial neoplasia

- Have an active, uncontrolled infection

- Are receiving any other investigational therapy

- Have received previous treatment with vosaroxin

- Are pregnant or lactating

- Have any other medical, psychological, or social condition that may interfere with
consent, study participation, or follow-up

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Up to 5 years or duration of study

Safety Issue:

No

Principal Investigator

Sunesis Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

VOS-AML-301

NCT ID:

NCT01191801

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Leukemia
  • Acute Myeloid Leukemia
  • Acute Nonlymphocytic Leukemia
  • Leukemia
  • Acute Myeloid Leukemia
  • Hematologic
  • Hematologic diseases
  • Blood
  • Cancer
  • Malignancy
  • Vosaroxin
  • Cytarabine
  • First Relapsed AML
  • Refractory AML
  • VALOR
  • Sunesis
  • Voreloxin
  • SNS-595
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Duke University Medical CenterDurham, North Carolina  27710
University of California San FranciscoSan Francisco, California  941104206
Family Cancer CenterCollierville, Tennessee  38017
Henry Ford Health SystemDetroit, Michigan  48202
Holy Cross HospitalFort Lauderdale, Florida  33308
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Sharp Clinical Oncology ResearchSan Diego, California  92123
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Baptist Cancer InstituteJacksonville, Florida  32207
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Stony Brook University Medical CenterStony Brook, New York  11794
UT Southwestern Medical Center at DallasDallas, Texas  75390
Weill Cornell Medical CollegeNew York, New York  10021
Mecklenburg Medical GroupCharlotte, North Carolina  
North Shore Long Island Jewish Health SystemLake Success, New York  11042
St. Francis Medical Group Oncology and Hematology SpecialistsIndianapolis, Indiana  46237
Georgia Health Sciences UniversityAugusta, Georgia  30912
Henry-Joyce Cancer ClinicNashville, Tennessee  37232-5536
UCLA Division of Hematology/OncologyLos Angeles, California  90095
HCA HealthONE - Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218
George Washington University-Medical Faculty AssociatesWashington, District of Columbia  20037
Rush University Medical Center, Division of Hematology/OncologyChicago, Illinois  60612
Ellis Fischel Cancer Center, University of Missouri Health CareColumbia, Missouri  65203
New York Medical College, Division of Oncology/HematologyValhalla, New York  10595
University Hospitals fo ClevelandCleveland, Ohio  44106
The University of Texas, M.D. Anderson Cancer Center, Department of LeukemiaHouston, Texas  77030
Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia UniversityMorgantown, West Virginia  26506