A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-03

Study Completion Date

2013-11-05

Brief Summary

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The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.

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Detailed Description

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Conditions

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Recurrent Glioblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PLX3397-Cohort 1

10 patients with recurrent glioblastoma who require reoperation will be treated with PLX3397 for 7 days prior to surgery and their tumor tissue will be evaluated for pharmacokinetic levels and pharmacodynamic effects.

Group Type EXPERIMENTAL

PLX3397

Intervention Type DRUG

Capsules administered once or twice daily, continuous dosing

PLX3397-Cohort 2

30 patients will be orally dosed with PLX3397 continuously on 28 day cycles.

Group Type EXPERIMENTAL

PLX3397

Intervention Type DRUG

Capsules administered once or twice daily, continuous dosing

Interventions

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PLX3397

Capsules administered once or twice daily, continuous dosing

Intervention Type DRUG

Other Intervention Names

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Pexidartinib

Eligibility Criteria

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Inclusion Criteria

* Male or female patients ≥18 years old with a life expectancy of at least 8 weeks
* Radiographically proven recurrent (≥ first relapse), intracranial Glioblastoma (GBM)
* For all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous GBM surgery
* Previous treatment with external beam radiation and temozolomide chemotherapy
* Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as follows:

\>28 days for cytotoxic therapy \>42 days for nitrosoureas \>28 days for bevacizumab \>7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib

* Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.
* Karnofsky performance status of ≥60
* Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb \>9 g/dL, platelet count ≥50 x 109/L, Aspartate aminotransferase/Alanine aminotransferase (AST/ALT) ≤2.5x Upper Limit of Normal (ULN), creatinine ≤1.5x ULN)
* Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion Criteria

* Investigational drug use within 28 days of the first dose of PLX3397
* GBM progression within 3 months of previous radiation by Response Assessment in Neuro-Oncology (RANO) criteria
* History of Grade 2 Common Toxicity Criteria for Adverse Events (CTCAE v4) or greater acute intracranial hemorrhage
* Previous failure of bevacizumab or other vascular endothelial growth factor (VEGF) therapy except in a first line setting
* History of malignant glioma with co-deletion of 1p/19q
* A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy). Prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years.
* Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
* Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
* Women of child-bearing potential who are pregnant or breast feeding
* corrected QT interval (QTc) ≥450 msec at Screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No