A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma

Stopped early · Phase 2

Conditions studied: Recurrent Glioblastoma

In brief

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

Key facts

Study ID: NCT01349036
Run by: Daiichi Sankyo
People needed: 38
Starts: 2011-12-03
Expected to finish: 2013-11-05
Last updated by the study team: 2020-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University California, Los Angeles — Los Angeles, California, United States
University California, San Francisco — San Francisco, California, United States
Dana Faber Cancer Institute — Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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