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A Phase 1b Trial of CB-839 in Combination with Radiation Therapy and Temozolomide in Patients with IDH-mutated Diffuse Astrocytoma and Anaplastic Astrocytoma
This phase 1b trial studies the side effects and best dose of glutaminase inhibitor CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating patients with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CB-839 with radiation therapy and temozolomide may work better than surgery, radiation therapy, and temozolomide in treating patients with IDH-mutated diffuse astrocytoma or anaplastic astrocytoma.
Primary Objective 1.1.1 Determine the MTD and/or the recommended Phase 2 dose (RP2D) of CB-839 HCl when combined with RT and TMZ in patients with newly diagnosed IDH-mutated diffuse DA and AA. Secondary Objectives 1.2.1 To observe and record anti-tumor activity. Although the clinical benefit of these drugs has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. - The anti-tumor activity will be estimated by the objective response rate (ORR) and the clinical benefit rate (CBR) for the combination of CB-839 HCl and RT/TMZ in IDH-mutated glioma based on Response Assessment in Neuro-Oncology (RANO) criteria. 1.2.2 Determine the safety and tolerability of RT/TMZ/CB-839 HCl in patients based on physician reported adverse event (AE) data. Determine the safety and tolerability of RT/TMZ/CB-839 HCl in patients based on physician reported adverse event (AE) data. 1.2.3 Estimate the 2-year progression-free survival (PFS2) of RT/TMZ/CB-839 HCl in patients with IDH-mutated glioma based on RANO criteria. 1.2.4 Estimate the 2-year overall survival (OS2) of RT/TMZ/CB-839 HCl in patients with IDH-mutated glioma based on RANO criteria.
CB-839 (Telaglenestat); Temodal (Temozolomide); Temozolomide ()