Phase I Trial of TURALIO(R) (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 ...

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 * S

Trial Details

NCT ID

NCT02390752

Phase

PHASE1

Sponsor

National Cancer Institute (NCI)

Status

RECRUITING

Cancer Type

Leukemia

Interventions

• TURALIO(R)

Locations (sample)

• Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

• Diagnosis:
• Individuals must have recurrent or refractory solid tumors or acute leukemia (limited to AML or ALL) or have been intolerant of prior therapies, co…
• In addition, individuals with NF1 and with malignant peripheral nerve sheath tumor (MPNST).
• Individuals must have relapsed after or be refractory to effective standard therapies. There are no limits on number of prior therapeutic regimens.

For full eligibility, visit ClinicalTrials.gov.

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