CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 54 enrolled / 54 target
Drug / intervention
Telaglenastat Hydrochloride +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03872427
NCT03872427Phase 2ActiveUpdate Overdue (0.7/mo)Completion was 32mo ago
CompareCT.gov

A Phase II Basket Trial of Glutaminase Inhibitor (BEGIN) Telaglenastat (CB-839) HCL in Patients With NF1 Aberrations, NF1 Mutant Malignant Peripheral Nerve Sheath Tumors (MPNST), KEAP1/NRF2 and LKB1 Aberrant Tumors

National Cancer Institute (NCI)·interventional·Posted Mar 13, 2019·Updated Jun 17, 2026

In Brief

A Phase 2 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 4 other interventions for Advanced Malignant Solid Neoplasm and 3 related conditions. Active but no longer recruiting, targeting 54 participants across 31 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial studies how well glutaminase inhibitor telaglenastat hydrochloride (CB-839 HCl) works in treating patients with specific genetic mutations and solid tumors or malignant peripheral nerve sheath tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Glutaminase converts an amino acid (building block of proteins) called glutamine to glutamate, which can support several cellular pathways. Telaglenastat hydrochloride works by blocking glutamine activity needed for the growth of cells. When this activity is blocked, the growth of cancer cells may stop and the cancer cells may then die. Cancer is caused by changes (mutations) to genes that control the way cells function and uncontrolled cell growth may result in tumor formation. Specific genetic mutations studied in this clinical trial are NF1 mutation for malignant peripheral nerve sheath tumors, and NF1, KEAP1/NRF2, or STK11/LKB1 mutation for other solid tumors. Telaglenastat hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor, Unresectable Malignant Solid Neoplasm
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedMar 13, 2019
Enrollment StartDec 14, 2019
Primary CompletionOct 30, 2023
Study CompletionApr 16, 2027
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.3 years ago

Arms & Interventions

Treatment (telaglenastat hydrochloride)experimental

Patients receive telaglenastat hydrochloride PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, or PET/CT during screening and on study, and collection of blood samples during screening and on study.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingOther: Pharmacodynamic StudyProcedure: Positron Emission TomographyDrug: Telaglenastat Hydrochloride

Interventions

Biospecimen Collectionprocedure

Undergo collection of blood

Computed Tomographyprocedure

Undergo CT or PET/CT

Magnetic Resonance Imagingprocedure

Undergo MRI

Pharmacodynamic Studyother

Correlative studies

Positron Emission Tomographyprocedure

Undergo PET/CT

Telaglenastat Hydrochloridedrug

Given PO