Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT01790503
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥18 years old.
* Histologically confirmed definitive GBM or gliosarcoma by partial or complete surgical resection (i.e. not by biopsy only) within 5 weeks prior to PLX3397 administration (C1D1). Tumor must have a supratentorial component. For all patients, availability of a surgical paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
* The patient must have recovered from the effects of surgery, post-operative infection, and other complications before study registration.
* A diagnostic contrast-enhanced MRI or CT scan of the brain must be performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days (preferably 14 days) prior to C1D1.
* Patients unable to undergo MR imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality.
* Patients must receive RT at the participating institution.
* Women of child-bearing potential must have a negative pregnancy test within 14 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, and for 3 months after the last dose.
* Karnofsky performance status of ≥70.
* Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.5x 109/L, Hgb \>10 g/dL, platelet count ≥100 x 109/L, AST/ALT ≤2.5x 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:
* Evidence of recurrent GBM or metastases detected outside of the cranial vault.
* Investigational drug use within 28 days of the first dose of PLX3397 or concurrently.
* Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment.
* Prior radiation or chemotherapy for glioblastoma or glioma.
* Prior chemotherapy or radiosensitizers for cancer of the head and neck (except for T1 glottic cancer) that would result in an overlap of radiation fields.
* Prior allergic reaction to temozolomide.
* History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage.
* Active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.
* Chronic active hepatitis B or C.
* Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of study drug.
* 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.
* At Screening QTcF ≥450 msec for males and ≥470 msec for females.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01790503
Study Brief:
Protocol Section:
NCT01790503