Clinical trialNCT01349049CompletedPhase 1/PHASE2Interventional

Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)

SponsorDaiichi SankyoEnrollment90Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to evaluate the safety of study drug PLX3397 at 3 dose levels (800 mg/day, 1000 mg/day, and 1200 mg/day) and explore the efficacy in patients with relapsed or refractory acute myeloid leukemia (AML). Additional dose levels beyond 1200 mg/day may be considered based on safety and efficacy observations.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alexander Perl, MD
Hospital of the University of Pennsylvania - Philadelphia, PA
Principal Investigator
clinicaltrials.gov ↗
Catherine Smith, MD
University of California Medical Center - San Francisco, CA
Principal Investigator
clinicaltrials.gov ↗
Eunice Wang, MD
Roswell Park Cancer Institute - Buffalo, NY
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Gail Roboz, MD
Weill Cornell Medical College/New York Presbyterian Hospital - New York, NY
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
John Pagel, MD, PhD
Fred Hutchinson Cancer Research Center - Seattle, WA
Principal Investigator
clinicaltrials.gov ↗
Mark Levis, MD, PhD
Johns Hopkins University
Principal Investigator
clinicaltrials.gov ↗
Olga Frankfurt, MD
Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago, IL
Principal Investigator
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Richard Stone, MD
Dana-Farber Cancer Institute - Boston, MA
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Ucsf Helen Diller Family Family Comprehensive Cancer Center
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presby Hospital, Weill Medical College at Cornell University
New York, New York, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Pexidartinib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Nov 2011
Primary completion: 20 Jan 2015
Completion: 9 Jan 2018
Last update posted: 2 Mar 2020
Registered enrollment: 90
Registry id: NCT01349049

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.