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NCT03872427 · ClinicalTrials.gov registry record · Phase 2
Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study
A Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT03872427: Active Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT03872427 is a Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03872427, a Phase 2 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Best overall response rate (BORR) based on RECIST V1.1 achieved by 6 months of CB-839 HCl treatment
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- OTHER Pharmacodynamic Study
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
- Moffitt Cancer Center-International Plaza - Tampa
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- The University of Kansas Cancer Center - Olathe - Olathe
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Illinois
- Northwestern University - Chicago
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-12-14 |
| Est. Completion | 2026-04-16 |
| Phase | Phase 2 |
What the registry record for NCT03872427 still lists
NCT03872427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (69% lower).
The record links to 4 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03872427 names 20 study sites across 5 states, led by Florida, Kansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT03872427 about?
NCT03872427 is a clinical study titled "Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study". 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 b...
What is the current status of trial NCT03872427?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2019-12-14. Estimated completion is 2026-04-16.
What conditions does trial NCT03872427 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm, NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor.
What interventions are being tested in trial NCT03872427?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Pharmacodynamic Study (OTHER).
Who is sponsoring clinical trial NCT03872427?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03872427 being conducted?
This trial has 20 study locations across Alabama, Florida, Illinois, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03872427's enrollment target sits among peer trials
54 41st of 108 higher than 66 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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