Al's Comment:
This is a new trial for newly diagnosed GBM or recurrent high grade glioma in adults (age 18+).
Posted on: 08/24/2018
New glioblastoma clinical trial: mTOR inhibitor ABI-009
Aadi Bioscience, Inc. in collaboration with John Wayne Cancer Institute, is conducting a clinical research study for patients with recurrent high-grade glioma or newly diagnosed glioblastoma.
The main goal of this research is to investigate the efficacy of the mTOR inhibitor ABI-009 in combination with existing therapies in patients with recurrent high-grade glioma or newly diagnosed glioblastoma. The experimental drug is a novel nanoparticle albumin-bound rapamycin (nab-rapamycin).
Study Design
•Prospective
•Multi-cohort
•Phase II, open label
•Non-randomized
•Single site
There are three (3) study periods:
1.A Screening Period to determine eligibility, which lasts approximately 3 weeks
2.A Treatment period, which lasts approximately 6 months for patients with recurrent high-grade glioma and up to 12 months for patients with newly diagnosed glioblastoma, where subjects receive weekly ABI-009 for 2 out of every 3 weeks or 3 out of every 4 weeks by IV infusion over 30 minutes
3.A Follow-up period to assess safety, survival and anticancer therapy, with phone call follow-up occurring every 12 weeks
Key Eligibility Criteria
Patients must have:
•Patients must have:
•≥18 years old
•KPS ≥ 70%
•No pregnancy or breastfeeding, contraception required
•For patients with recurrent high-grade glioma:
–All patients must have histologic evidence of high grade glioma (World Health Organization [WHO] grade 3 or grade 4) and radiographic evidence of recurrence or disease progression
–No prior mTOR inhibitors or BEV or other anti-angiogenic agents, no prior treatment with respective agent for recurrent disease in combo cohorts
•For patients with newly diagnosed glioblastoma:
–Patients must have had surgery and have a measurable post-contrast lesion after surgery detected by MRI.
–No prior mTOR inhibitors and no prior local or systemic therapy for GBM.
You may reference additional study information on ClinicalTrials.gov at: https://www.clinicaltrials.gov/ct2/show/NCT03463265
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