A Phase 1, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Clinical Activity of IGN523 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor study identifier
interventional
19
1 country
6
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
June 2015
Actual (reported)This study will examine the safety and tolerability of IGN523 administered as an IV infusion. The main purpose of the study is to determine the maximum tolerated dose (MTD), which is the highest dose that does not cause unacceptable side effects of IGN523 in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of IGN523. In addition, the pharmacokinetic profile and anti-leukemia activity of IGN523 will be assessed. A recommended Phase 2 dose (RP2D) of IGN523 will be identified, on the basis of safety, pharmacokinetic (PK), and pharmacodynamic (PD) data.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2014
Actual (reported)January 20, 2014
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)June 2015
Actual (reported)Incidence of adverse events
Through 1 month following last dose
Incidence of antidrug antibodies to IGN523
Through 6 months following last dose
Blood concentrations of IGN523
Through 6 months following last dose
Assess anti-leukemic activity of IGN523
Initial assessment after 8 weeks of treatment
IGN523
Given intravenously every week for 8 weeks. Dosing beyond 8 weeks will be permitted for subjects meeting criteria for ongoing clinical benefit and acceptable safety.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCSD Medical Center / Thornton Hospital
La Jolla, California, 92037, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Indiana Blood and Marrow Transplantation Clinic
Indianapolis, Indiana, 46237, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98109, United States
William Ho, MD, PhD
Igenica Biotherapeutics, Inc.
19 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2014
First Posted
January 20, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older
Contact the study team to confirm eligibility.
Primary Completion
March 2015
Actual (reported)Study Completion
June 2015
Actual (reported)Last Updated
February 23, 2016
Record last verified: 2016-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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