Who is sponsoring NCT03872427?

NCT03872427 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT03872427?

Interventions in NCT03872427: Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pharmacodynamic Study, Positron Emission Tomography, Telaglenastat Hydrochloride.

What condition does NCT03872427 study?

NCT03872427 studies Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor, Unresectable Malignant Solid Neoplasm.

Is NCT03872427 still recruiting?

NCT03872427 is currently active, enrolled. Last updated 14 November 2025.

Are results published for NCT03872427?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-11-14 · How we verify

NCT03872427

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study

Active, enrolled Phase 2 Results posted Last updated 14 November 2025

What this trial tests

Phase 2 trial testing Biospecimen Collection in Advanced Malignant Solid Neoplasm in 54 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 December 2019

Primary endpoint
30 October 2023

16 April 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	14 December 2019
Primary completion	30 October 2023
Estimated completion	16 April 2026
Sites	31 locations across United States

Drugs / interventions tested

Biospecimen Collection — full drug profile →
Computed Tomography
Magnetic Resonance Imaging
Pharmacodynamic Study
Positron Emission Tomography
Telaglenastat Hydrochloride — full drug profile →

Conditions studied

Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor — all drugs for NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor →
Unresectable Malignant Solid Neoplasm — all drugs for Unresectable Malignant Solid Neoplasm →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Advanced Malignant Solid Neoplasm or Metastatic Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Best Overall Response Rate by 6 Months Primary · Up to 6 months from treatment start date

Best overall response rate (BORR) based on RECIST V1.1 achieved by 6 months of CB-839 HCl treatment

Complete Response (CR)/Partial response (PR)

Group	Value	95% CI
Cohort 1	0
Cohort 2	1
Cohort 3	0
Cohort 4	0

Stable Disease (SD)

Group	Value	95% CI
Cohort 1	4
Cohort 2	10
Cohort 3	2
Cohort 4	4

Progressive disease (PD)

Group	Value	95% CI
Cohort 1	4
Cohort 2	14
Cohort 3	6
Cohort 4	5

Treatment Failure

Group	Value	95% CI
Cohort 1	1
Cohort 2	1
Cohort 3	1
Cohort 4	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1

Serious: 5/9 (56%)

Deaths: 7/9

Cohort 2

Serious: 7/26 (27%)

Deaths: 20/26

Cohort 3

Serious: 4/9 (44%)

Deaths: 6/9

Cohort 4

Serious: 6/10 (60%)

Deaths: 8/10

Serious adverse events (33 terms)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Constipation	Gastrointestinal disorders	—	—	—	—
Death NOS	General disorders	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Tracheal obstruction	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Acute kidney injury	Injury, poisoning and procedural complications	—	—	—	—
Appendicitis	Gastrointestinal disorders	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Bacteremia	Blood and lymphatic system disorders	—	—	—	—
Blood bilirubin increased	Blood and lymphatic system disorders	—	—	—	—
Chest wall pain	Cardiac disorders	—	—	—	—
Colonic obstruction	Gastrointestinal disorders	—	—	—	—
Encephalopathy	Nervous system disorders	—	—	—	—
Esophageal obstruction	Gastrointestinal disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Gait disturbance	Musculoskeletal and connective tissue disorders	—	—	—	—
General and admin site - Other - Failure To Thrive	General disorders	—	—	—	—
Generalized edema	General disorders	—	—	—	—
Generalized muscle weakness	General disorders	—	—	—	—
Hypercalcemia	Blood and lymphatic system disorders	—	—	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—	—	—
Hyponatremia	Blood and lymphatic system disorders	—	—	—	—
Hypoxia	General disorders	—	—	—	—

Other adverse events (144 terms — click to expand)

Reaction	System	Cohort 1	Cohort 2	Cohort 3	Cohort 4
ALT increased	Investigations	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—
Fatigue	General disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—	—
AST increased	Investigations	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Photophobia	Nervous system disorders	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—
White blood cell decreased	Investigations	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—
Creatinine increased	Investigations	—	—	—	—
Weight loss	Metabolism and nutrition disorders	—	—	—	—
Elevated LDH	Investigations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Blood bilirubin increased	Blood and lymphatic system disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—
Fall	General disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Peripheral motor neuropathy	Nervous system disorders	—	—	—	—
Floaters	Eye disorders	—	—	—	—

Most-reported serious reactions: Constipation, Death NOS, Dyspnea, Pain, Tracheal obstruction, Abdominal pain, Acute kidney injury, Appendicitis.

Data from ClinicalTrials.gov NCT03872427 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols.
Park JJH, Siden E, Zoratti MJ, Dron L, et al · · 2019 · cited 260× · PMID 31533793 · DOI 10.1186/s13063-019-3664-1
Enhancing the Efficacy of Glutamine Metabolism Inhibitors in Cancer Therapy.
Yang WH, Qiu Y, Stamatatos O, Janowitz T, et al · · 2021 · cited 222× · PMID 34020912 · DOI 10.1016/j.trecan.2021.04.003
Metabolic networks in mutant KRAS-driven tumours: tissue specificities and the microenvironment.
Kerk SA, Papagiannakopoulos T, Shah YM, Lyssiotis CA. · · 2021 · cited 182× · PMID 34244683 · DOI 10.1038/s41568-021-00375-9
NRF2: KEAPing Tumors Protected.
Pillai R, Hayashi M, Zavitsanou AM, Papagiannakopoulos T. · · 2022 · cited 151× · PMID 35101864 · DOI 10.1158/2159-8290.cd-21-0922
Barriers and opportunities for gemcitabine in pancreatic cancer therapy.
Beutel AK, Halbrook CJ. · · 2023 · cited 108× · PMID 36571444 · DOI 10.1152/ajpcell.00331.2022
A glutamine tug-of-war between cancer and immune cells: recent advances in unraveling the ongoing battle.
Wang B, Pei J, Xu S, Liu J, et al · · 2024 · cited 81× · PMID 38459595 · DOI 10.1186/s13046-024-02994-0
Regulation of antioxidants in cancer.
Hecht F, Zocchi M, Alimohammadi F, Harris IS. · · 2024 · cited 79× · PMID 38029751 · DOI 10.1016/j.molcel.2023.11.001

Verify or expand the search:

Other trials of Biospecimen Collection

Trials testing the same drug.

NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07365306 — Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant · Phase 2 · not yet recruiting
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting

Other recruiting trials for Advanced Malignant Solid Neoplasm

Currently open trials in the same condition.

NCT07141407 — Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and T · NA · recruiting
NCT07189195 — TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory · Phase 1 · recruiting
NCT07174661 — Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid · NA · recruiting
NCT06223542 — Studying TAK-243 in Patients With Advanced Cancer · Phase 1 · recruiting
NCT06311214 — Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastati · Phase 2 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03872427 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 14 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03872427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing