ASH Clinical News ACN_4.14_Full Issue_web | Page 43
Idasanutlin (RG7388): an investigational MDM2 antagonist
Currently Enrolling
Phase III Clinical Trial of Idasanutlin
in Relapsed/Refractory AML* †
A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study of Idasanutlin, an MDM2
Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory
Acute Myeloid Leukemia (AML)
Cycle 1
Schema
Phase III
Relapsed/Refractory AML
(N=440)
Idasanutlin
+
Cytarabine
Randomized
•
Idasanutlin
+
Cytarabine
Cycles 2-3: Optional
Patients Responding
Placebo
+
Cytarabine
Selected eligibility criteria
OS in TP53 wild-type population
18 years of age and older
Documented diagnosis of fi rst or second R/R
AML using WHO classifi cation
• Maximum of 2 prior induction regimens, one of
which included cytarabine with an anthracycline
• ECOG performance status of 0-1
• Adequate hepatic and renal function
•
•
Selected secondary outcome measures
•
•
•
•
•
•
•
Patients Responding
Cycle 1
Placebo
+
Cytarabine
Primary outcome measure
Cycles 2-3: Optional
OS in overall population
Overall remission rate, including CR, CRp
Percentage of patients in CR
Percentage of patients in CRp
EFS
LFS
Percentage of patients with an allogeneic HSCT
For more information about the Idasanutlin (RG7388) clinical trial:
Visit:
MIRROSstudy.com
Email:
[email protected]
888-662-6728 (U.S. and Canada only)
ClinicalTrials.gov Identifier: NCT02545283; Sponsor Study Identifier: WO29519.
CR=complete remission; CRp=complete remission with incomplete platelet count recovery; ECOG=Eastern Cooperative Oncology Group;
EFS=event-free survival; HSCT=hematopoietic stem cell transplant; LFS=leukemia-free survival; MDM2=murine double minute 2; OS=overall survival;
R/R=relapsed or refractory; WHO=World Health Organization.
* Product under investigation has not been approved for use outside the clinical trial setting. This information is presented only for the purpose of providing
an overview of the clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.
†
All trial information consistent with clinicaltrials.gov/ct2/show/NCT02545283 as of September 4, 2018.
© 2018 Genentech USA, Inc. All rights reserved. BIO/102115/0196(2)d