Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Public ClinicalTrials.gov record NCT01349049. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory FLT3-ITD Positive Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01349049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2011
- Primary completion
- Jan 19, 2015
- Completion
- Jan 8, 2018
- Last update posted
- Mar 1, 2020
2011 – 2018
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Helen Diller Family Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Johns Hopkins University | Baltimore | Maryland | 21231 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | — |
| New York Presby Hospital, Weill Medical College at Cornell University | New York | New York | 10065 | — |
| University of Pennsylvania, Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01349049, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2020 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01349049 live on ClinicalTrials.gov.