VALOR is a pivotal Phase 3, randomized, controlled, double-blind, multinational clinical
trial evaluating the efficacy and safety of vosaroxin (VŌZ-ah-rox-in)—a first-in-class anticancer quinolone derivative (AQD)—plus cytarabine versus placebo plus
cytarabine for patients with first relapsed or refractory acute myeloid leukemia (AML).

  • 90% power to detect a 40% improvement in overall survival.

  • Innovative, adaptive trial design allows for a one-time sample size adjustment by
    the Data Safety Monitoring Board at the interim analysis to ensure adequate power
    across a broader range of clinically meaningful and statistically significant survival
    outcomes.

  • Dose and schedule: Vosaroxin 90 mg/m2 10-minute infusion or placebo on days 1
    and 4; cytarabine (IDAC) 1 g/m2 given as a 2-hour IV infusion on days 1 through 5.

  • In a Phase 2 trial in patients who mirror the entry criteria for VALOR, the vosaroxin
    plus cytarabine regimen resulted in a median overall survival of 7.1 months, and a
    combined complete remission rate (CR+CRp+CRi) of 29% (CR rate of 25%). Early
    mortality rates were low, with 30-day and 60-day all-cause mortality rates of 3%
    and 9%, respectively. Infection-related toxicities were the most common Grade 3
    or higher nonhematologic adverse events.1

AML=acute myeloid leukemia; CR=complete remission; ECOG=Eastern Cooperative Oncology Group; GVHD=graft-versus-host disease;
HIDAC=high-dose Ara-C; HSCT=hematopoietic stem cell transplant; IDAC=intermediate-dose Ara-C; WHO=World Health Organization.


For complete information on the trial, please see VALOR on clinicaltrials.gov
VALOR Trial Site Locations
 
United States International
La Jolla, CA
Los Angeles, CA
San Diego, CA
San Francisco, CA
Denver, CO
Washington, D.C.
Fort Lauderdale, FL
Jacksonville, FL
Tampa, FL
Augusta, GA
Chicago, IL
Indianapolis, IN
Iowa City, IA
New Orleans, LA
Ann Arbor, MI
Detroit, MI
Columbia, MO
Lebanon, NH
Hackensack, NJ
Lake Success, NY
New York, NY
Stony Brook, NY
Valhalla, NY
Charlotte, NC
Durham, NC
Winston-Salem, NC
Cleveland, OH
Charleston, SC
Memphis, TN
Nashville, TN
Dallas, TX
Houston, TX
San Antonio, TX
Morgantown, WV
Adelaide, SA, Australia
Bedford Park, SA, Australia
Brisbane, QLD, Australia
Concord, NSW, Australia
Garran, ACT, Australia
Geelong, VIC, Australia
Gosford, NSW, Australia
Melbourne, VIC, Australia
Parkville, VIC, Australia
Perth, WA, Australia
Westmead, NSW, Australia
Graz, Austria
Innsbruck, Austria
Salzburg, Austria
Wein, Austria
Antwerp, Belgium
Bruges, Belgium
Brussels, Belgium
Leuven, Belgium
Roeselare, Belgium
Greenfield Park, QC, Canada
Halifax, NS, Canada
Saint John, NB, Canada
Toronto, ON, Canada
Vancouver, BC, Canada
Brno Czech Republic Hradec Kralove, Czech Republic Prague, Czech Republic Angers, France
Bobigny, France
Le Chesnay, France
Lille Cedex, France
Marseille, France
Nantes, France
Pessac, France
Pierre-Bénite, France
Toulouse, France
Duisburg, Germany
Frankfurt, Germany
Hamburg, Germany
Hannover, Germany
Heilbronn, Germany
Kiel, Germany
Leipzig, Germany
Muenster, Germany
Munich, Germany
Debrecen, Hungary
Gyor, Hungary
Kaposvar, Hungary
Szeged, Hungary
Brindisi, Italy
Ferrara, Italy
Genova, Italy
Lecce, Italy
Napoli, Italy
Novara, Italy
Pavia, Italy
Seoul, Korea
Auckland, New Zeland
Christchurch, New Zealand
Hamilton, New Zealand
Palmerston North, New Zealand
Gdansk, Poland
Poznan, Poland
Wroclaw, Poland
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain
Salamanca, Spain Valencia, Spain Blackpool, United Kingdom
Cambridge, United Kingdom
Cardiff, United Kingdom
Cottingham, United Kingdom
Leicester, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom
 

If you treat AML,
consider whether any of your
patients are eligible for
enrollment in the VALOR trial.

OR

If you have AML,
or know someone who does,

gather more information on AML
and the VALOR trial.

Contact Sunesis Clinical Development at 888-71-VALOR or valortrial@sunesis.com.




Advocacy Groups  

Additional Resources  


References:
1. Roboz GJ, et al. Poster presented at: American Society of Clinical Oncology 2010 Annual Meeting;
June 4-8, 2010; Chicago, Illinois. Abstract 6526. 2. Hoch U, et al. Cancer Chemother Pharmacol. 2009;64:53-65. 3. Hawtin RE, et al. PLoS ONE. 2010;5:e10186. doi:10.1371/journal.pone.0010186. 4. Roboz GJ, et al. J Clin Oncol. 2010;28:15s. Abstract 6526. 5. Hirte HW, et al. Poster presented at: American Society of Clinical Oncology 2010 Annual Meeting; June 4-8, 2010; Chicago, Illinois. Abstract 5002. 6. Hawtin RE, et al. Oncotarget. 2010;1:606-619. 7. Walsby EJ, et al. Blood. 2009;114. Abstract 4152. 8. Evanchik MJ, et al. Drug Metab Dispos. 2009;37:594-601. 9. Scatena CD, et al. Cancer Chemother Pharmacol. 2010;66:881-888. 10. Advani RH, et al. Clin Cancer Res. 2010;16:2167-2175. 11. Creasey WA, et al. Cancer Res. 1976;36:216-221. 12. Greene W, et al. Cancer. 1972;30:1419-1427. 13. Gewirtz D. Biochem Pharmacol. 1999;57:727-741. 14. Skeel RT. Handbook of Cancer Chemotherapy. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2003:98–99, 425.

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