CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 54 target
Drug / intervention
TURALIO(R)drug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Recurrent or refractory solid tumors or acute leukemia (AML or ALL) or intolerant of prior therapies
  • ✓NF1 with malignant peripheral nerve sheath tumor (MPNST)
  • ✓Relapsed after or refractory to effective standard therapies
  • ✓Evaluable or measurable disease at enrollment
Key exclusion· 9
  • ✕Pregnant or breast feeding or becoming pregnant during trial
  • ✕Ongoing treatment with other cancer therapy or investigational agent (except IT chemotherapy for leukemia)
  • ✕Require therapy with warfarin
  • ✕Uncontrolled intercurrent illness including infection, heart failure, cardiac arrhythmia, or psychiatric illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02390752
NCT02390752Phase 1RecruitingOn Track
Long Recruiting
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Phase I Trial of TURALIO (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor (TGCT)

National Cancer Institute (NCI)·interventional·Posted Mar 18, 2015·Updated Jun 30, 2026

In Brief

A Phase 1 clinical trial evaluating TURALIO(R) for Neurofibroma, Plexiform and 3 related conditions. Currently recruiting, targeting 54 participants across 1 site.

Detailed Summary

Background: \- Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing. Objectives: \- To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer. Eligibility: \- People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies. Design: * Individuals will be screened with: * Medical history * Physical exam * Blood and urine tests * Heart tests * Scans or other tests of the tumor * Individuals will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years. * During the study, participants will have many tests and procedures. They include repeats of the screening tests. Individuals will keep a diary of symptoms. * Individuals with solid tumors will have scans or x-rays. * Individuals with leukemia will have blood tests. They may have a bone marrow sample taken. * Some individuals may have a biopsy. * When finished taking TURALIO(R), individuals will have follow-up visits. They will repeat the screening tests and note side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurofibroma, Plexiform, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Promyelocytic, Acute, Sarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 1Recruiting
201520162017201820192020202120222023202420252026202720282029
First PostedMar 18, 2015
Enrollment StartApr 29, 2015
Primary CompletionDec 31, 2026
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 11.3 years agoPrimary completion in 6 months

Arms & Interventions

Phase Iexperimental

take oral drug daily for a 28 day cycle

Drug: TURALIO(R)

Interventions

TURALIO(R)drug

take oral drug daily for a 28 day cycle