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Last Updated: September 19, 2020

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CLINICAL TRIALS PROFILE FOR PLX3397

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Clinical Trials for PLX3397

Trial ID Title Status Sponsor Phase Summary
NCT01004861 Safety Study of PLX108-01 in Patients With Solid Tumors Active, not recruiting Plexxikon Phase 1 PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood, plasma and urine biomarkers of Fms activity.
NCT01042379 I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer Recruiting QuantumLeap Healthcare Collaborative Phase 2 The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.
NCT01090570 Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate Withdrawn Plexxikon Phase 1 PLX3397 is a selective inhibitor of Fms and Kit activity. The objective of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) of orally administered PLX3397 during 2 weeks of dosing in patients with rheumatoid arthritis (RA) who are on maintenance methotrexate. This study is planned to provide data to inform dose selection for a subsequent 12 week dose ranging study in RA.
NCT01217229 Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma Completed Plexxikon Phase 2 PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL). Secondary objectives include safety, the duration of response, the disease control rate, progression free survival, and how the drug affects your body.
NCT01349036 A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma Completed Plexxikon Phase 2 The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.
NCT01349049 Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML) Active, not recruiting Plexxikon Phase 1/Phase 2 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.
NCT01499043 Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC) Completed Plexxikon Phase 2 The main objective of this study is to evaluate the effects on the body that PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the antitumor effects that PLX3397 has on the the subjects.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for PLX3397

Condition Name

Condition Name for
Intervention Trials
Sarcoma 2
Gastric Cancer 2
Tenosynovial Giant Cell Tumor 2
Leukemia, Prolymphocytic, Acute 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Melanoma 4
Giant Cell Tumors 3
Nerve Sheath Neoplasms 2
Prostatic Neoplasms 2
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Clinical Trial Locations for PLX3397

Trials by Country

Trials by Country for
Location Trials
United States 106
Australia 5
France 3
United Kingdom 3
Italy 3
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Trials by US State

Trials by US State for
Location Trials
California 13
New York 10
Massachusetts 8
Texas 7
Washington 6
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Clinical Trial Progress for PLX3397

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 10
Not yet recruiting 4
Active, not recruiting 4
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Clinical Trial Sponsors for PLX3397

Sponsor Name

Sponsor Name for
Sponsor Trials
Plexxikon 15
National Cancer Institute (NCI) 2
Centre Leon Berard 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 20
Other 8
NIH 2
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