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

NCT01349049 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-03-02

Study results available
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Summary

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.

Conditions

Interventions

DRUG

PLX3397

Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily.

DRUG

PLX3397

The drug product is available in capsule form, to be taken orally.

Sponsors & Collaborators

Principal Investigators

  • Olga Frankfurt, MD · Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago, IL

  • Mark Levis, MD, PhD · Johns Hopkins University

  • John Pagel, MD, PhD · Fred Hutchinson Cancer Research Center - Seattle, WA

  • Alexander Perl, MD · Hospital of the University of Pennsylvania - Philadelphia, PA

  • Gail Roboz, MD · Weill Cornell Medical College/New York Presbyterian Hospital - New York, NY

  • Catherine Smith, MD · University of California Medical Center - San Francisco, CA

  • Richard Stone, MD · Dana-Farber Cancer Institute - Boston, MA

  • Eunice Wang, MD · Roswell Park Cancer Institute - Buffalo, NY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-21
Primary Completion
2015-01-20
Completion
2018-01-09

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01349049 on ClinicalTrials.gov