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A Phase 2 Study of Orally Administered PLX3397 in Patients With Recurrent Glioblastoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Glioblastoma

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Trial Information

A Phase 2 Study of Orally Administered PLX3397 in Patients With Recurrent Glioblastoma

Inclusion Criteria:

- Male or female patients ≥18 years old with a life expectancy of at least 8 weeks

- Radiographically proven recurrent (≥ first relapse), intracranial 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

- Previous treatment with external beam radiation and temozolomide chemotherapy

- Before the first dose of PLX3397,adequate recovery from toxicity of prior therapy as

>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, AST/ALT ≤2.5x ULN, creatinine ≤1.5x

- 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 RANO criteria

- History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage

- Previous failure of bevacizumab or other 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

- QTc ≥450 msec at Screening

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety-Subject incidence of adverse events

Outcome Description:

Subjects will take oral doses of PLX3397 twice a day. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology and serum chemistry will be used to assess safety throughout the study. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.

Outcome Time Frame:

1 year

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

September 2013

Related Keywords:

  • Recurrent Glioblastoma
  • GBM
  • Glioblastoma
  • brain cancer
  • Glioblastoma



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University California, San FranciscoSan Francisco, California  94143
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Dana Faber Cancer InstituteBoston, Massachusetts  02115
University California, Los AngelesLos Angeles, California  90095
Huntsman Cancer Institute University of UtahSalt Lake City, Utah  84132