Cytel-Designed Adaptive Confirmatory Study Poster Accepted at ASCO 2011
Study recognized for “Promising Zone” approach innovated by Cytel adaptive trial pioneer Cyrus R. Mehta and colleagues
Cambridge, MA, USA - May 19, 2011 - Cytel Inc., the premier provider of adaptive clinical trial services and biostatistical software, today announced that a jointly authored review of Sunesis Pharmaceuticals’ VALOR trial adaptive design will be presented at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting.
The Sunesis-sponsored VALOR pivotal phase 3 study is among the first application of a “Promising Zone” adaptive trial and is a directly attributable result of Cytel’s pioneering research in sample size re-estimation designs. The adaptive approach benefits study sponsors by enabling conditional investment of sample size resources (costs associated with the number of patients enrolled) in pre-determined stages. Starting with a comparatively conservative patient commitment, additional subjects are added to the trial only if justified by the interim analysis data results.
Cytel’s President and Co-Founder, Cyrus R. Mehta and eminent co-author Stuart Pocock of the London School of Hygiene and Tropical Medicine, detail the underlying statistical methods in Adaptive Increase in Sample Size when Interim Results are Promising. This peer-reviewed 2010 publication includes actual cardiology and neurology confirmatory trial examples.
For studies focused on oncology, cardiology, hepatitis, liver disease and other severe time-to-event applications, adaptive sample size re-estimation (SSR) methods are now increasingly acceptable to international regulators in later stage studies. The same SSR trial design capabilities are now available in Cytel’s East® SurvAdapt software.
About the Session
Adaptive Design of VALOR, a Phase 3 Trial of Vosaroxin or Placebo in Combination with Cytarabine for Patients with First Relapsed or Refractory Acute Myeloid Leukemia
Trials in Progress Poster Session - Monday, June 6, 8:00A - 12:00P CT
Board 48G - Abstract #TPS201 - McCormick Place - Hall A
About Valor
VALOR is a phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is currently open for enrollment and patients will be randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes.
About Cytel
Cytel Inc. is a leading provider of clinical research services and trial design and analysis software primarily for the biopharmaceutical, medical device, academic and government research markets.
All 25 leading global biopharmaceutical companies use Cytel technology to design, simulate and analyze their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial designed by Cytel has been accepted by international regulators.
Interview requests and further information:
Michael Weitz
Marketing Director
617.661.2011
mweitz@cytel.com