Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of NEO212, how the body handles it, and how well it treats cancer. It is for adults with worsening astrocytoma IDH-mutant or glioblastoma IDH-wildtype, two types of brain cancer, or certain cancers that have spread to the brain and are not controlled. NEO212 is given alone for these brain cancers or with selected standard treatments for cancer that has spread to the brain.
This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain. The study will have three phases, Phase 1, Phase 2a and Phase 2b.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18, understand and sign a consent form, and be able to complete study tests.
- Have one of the listed brain cancers after radiation, with or without temozolomide, or certain cancers that have spread to the brain despite surgery or radiation. Treatment and tumor measurement rules depend on the study phase.
- Meet the study's daily activity requirements and be expected to live at least 3 months.
- Have a brain MRI with contrast dye within 14 days before NEO212. People with certain cancers also need CT scans of the neck, chest, belly, and pelvis.
- Have healthy enough blood counts, liver, and kidneys. Side effects from past treatment must be gone or mild, and required breaks from past medicines must be completed.
- Have a stable or lower steroid dose for at least 5 days before consent. If you have seizures, they must be controlled on a stable medicine dose for 14 days before consent.
- If cancer worsens within 90 days of focused radiation, it must be outside the treated area or confirmed by a tissue sample or surgery.
- Men and women who could become pregnant must use birth control or avoid sex from 30 days before treatment until 90 days after treatment. Women who could become pregnant need a negative blood pregnancy test within 7 days before NEO212.
Who can't join
- Receive other cancer treatment during Phase 1, or standard treatment not allowed by the study during Phase 2a or 2b.
- Have cancer that has spread into the spinal cord or the coverings of the brain and spinal cord, including a past history of spread to these coverings.
- Have had focused radiation to tumors in the brain or spinal cord within 2 weeks before NEO212, or surgery within 7 days before consent.
- Have another cancer diagnosed within the past 5 years, except basal cell or squamous cell skin cancer.
- Have certain abnormal heart rhythm test results, risk factors for a dangerous heart rhythm, or take medicines that can cause these rhythm changes.
- Still have more than mild side effects from chemotherapy, immune treatment, or radiation.
- Have taken perillyl alcohol before or had an allergic reaction to it.
- For Phase 2b brain cancer patients: have had the original brain tumor return or worsen more than once.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patient must be ≥ 18yrs of age. * Patient must have the ability to understand, and the willingness to sign, a written informed consent form. * Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent. * Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212. * If progression of disease occurs within 90 days or conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection. * Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60. * Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Patient must have an expected survival or at least three months. * Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212. * Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212. * Patients must be able to comply with all study assessments. * If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent. * Patient must have adequate organ and marrow function as follows: * Absolute neutrophil count ≥ 1,500/microliter * Platelets ≥ 100,000/microliter * Total bilirubin within normal institutional limits * AST (SGOT) / ALT (SPGT) ≤ 2.5 x institutional upper limit of normal * Creatinine clearance (CrCl) of \>60 mL/min (using the Cockcroft-Gault formula or 24- hour urine collection). * Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy. A female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months). * A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212. * A serum pregnancy test will be repeated immediately if pregnancy is suspected. Phase 1: (dose escalation) * Patient must: * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens. * Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of: * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent; * 2 weeks from administration of immunotherapies; * 28 days from administration of cytotoxic agents; and * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine). NOTE: No washout is necessary for alternating electrical fields. Phase 2a: (safety run-in) * Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens. * Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens. * Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria. * Patient must have measurable/evaluable systemic disease per RECIST v1.1 criteria. Phase 2b: (efficacy) * Patient must: * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens. * Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens. * Patient must have measurable/evaluable CNS disease per RANO or RANO-BM criteria * Patient with select solid tumors must have measurable/evaluable systemic disease per RECIST v1.1 criteria. * Creatinine clearance (CrCl) of \>60 mL/min (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria: (all Phases) * Patient in Phase 1 concurrently receiving any other antitumor therapy. * Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1. * Patients with metastases to the spinal cord parenchyma. * Patients with metastases to the meninges. * Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212. * Patient with history of known leptomeningeal involvement. * Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin. * Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and/or the use of concomitant medications that prolong QT/QTc interval. * Patient had surgery within 7 days prior to the date of informed consent. * Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy. * Patient had prior treatment with perillyl alcohol. * Patient has a history of allergic reactions attributed to perillyl alcohol. * Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his/her primary CNS tumor(s).
Study sites (8)
CA
- Precision NextGen Oncology · Beverly Hills, CA 90212Jing Liu, MD MA · Study contact · (424) 777-0708 · JingL@nextgenonc.comKamlesh Sankhala, MD · Principal investigatorMore trials in Beverly Hills
- OPN Healthcare, Inc · Glendale, CA 91203Heather Lyon · Study contact · heatherl@opnhc.comVu Phan, MD · Principal investigatorMore trials in Glendale
- University of Southern California · Los Angeles, CA 90033Sandy Tran · Study contact · (323) 865-3980 · Sandy.Tran@med.usc.eduFrances Chow, MD · Principal investigatorMore trials in Los Angeles
FL
- MDR Core Network · Boynton Beach, FL 33426Ismaray Hernandez · Study contact · ismaray@mdrcore.comRobert Levin, MD · Principal investigatorMore trials in Boynton Beach
MA
- Tufts Medical Center · Boston, MA 21111Christian Lawlor · Study contact · Christian.Lawlor@tuftsmedicine.orgSoma Sengupta, MD · Study contactMore trials in Boston
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Amanda Nolen · Study contact · amanda.nolen@vumc.orgAlexander Mohler, MD · Principal investigatorMore trials in Nashville
TX
- Baylor, Scott and White Research Institute · Dallas, TX 75246Tarah Satterfield · Study contact · Tarah.Satterfield@bswhealth.orgDivya Mella, MD · Principal investigatorMore trials in Dallas
WA
- Northwest Medical Specialties · Tacoma, WA 98405Sheila Marsh · Study contact · 253-380-8173 · smarsh@nwmsonline.comJorge Chaves, MD · Principal investigatorMore trials in Tacoma