Trial · NCT03872427
Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study
NCT03872427, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-07-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study. Trials, record NCT03872427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03872427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study
- NCT number
- NCT03872427
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor, Unresectable Malignant Solid Neoplasm
- Interventions
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Pharmacodynamic Study, Positron Emission Tomography, Telaglenastat Hydrochloride
- First posted
- 2019-03-13
- Last updated
- 2026-11-02
- Results first posted
- 2025-07-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate by 6 Months | 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 |
| Secondary | Incidence of Adverse Events | Up to 2 years from treatment start date | Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Will tabulate toxicity by cohort, type, severity and attribution. |
| Secondary | Progression-free Survival | Time to progression or death whichever comes first, assessed up to 2 years from treatment start date | Will estimate using the Kaplan-Meier method with time zero set to cycle 1, day 1 (C1D1). Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death. |
| Secondary | Time to Progression | Time to progression starting at C1D1, assessed up to 2 years from treatment start date | Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death. |
| Secondary | Overall Survival | Time to death from any cause, assessed up to 2 years from treatment start date | Will estimate using the Kaplan-Meier method with time zero set to C1D1. Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death. |
| Secondary | Overall Response Rate | From start of treatment until disease progression/recurrence, assessed up to 2 years | |
| Secondary | Clinical Benefit Rate | Up to 2 years from treatment start date | |
| Other | Pharmacodynamic (PD) Tumor Oncometabolite Levels of Glutamine | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose | Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis. |
| Other | PD Tumor Oncometabolite Levels of Glutamate | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose | Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis. |
| Other | PD Tumor Oncometabolite Levels of Aspartate | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose | Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate by 6 Months | Up to 6 months from treatment start date | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Adverse Events | Up to 2 years from treatment start date | |||
| SECONDARY | Progression-free Survival | Time to progression or death whichever comes first, assessed up to 2 years from treatment start date | |||
| SECONDARY | Time to Progression | Time to progression starting at C1D1, assessed up to 2 years from treatment start date | |||
| SECONDARY | Overall Survival | Time to death from any cause, assessed up to 2 years from treatment start date | |||
| SECONDARY | Overall Response Rate | From start of treatment until disease progression/recurrence, assessed up to 2 years | |||
| SECONDARY | Clinical Benefit Rate | Up to 2 years from treatment start date | |||
| OTHER_PRE_SPECIFIED | Pharmacodynamic (PD) Tumor Oncometabolite Levels of Glutamine | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose | |||
| OTHER_PRE_SPECIFIED | PD Tumor Oncometabolite Levels of Glutamate | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose | |||
| OTHER_PRE_SPECIFIED | PD Tumor Oncometabolite Levels of Aspartate | Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate by 6 Months | Cohort 1 | Complete Response (CR)/Partial response (PR) | 0 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 2 | Complete Response (CR)/Partial response (PR) | 1 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 3 | Complete Response (CR)/Partial response (PR) | 0 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 4 | Complete Response (CR)/Partial response (PR) | 0 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 1 | Stable Disease (SD) | 4 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 2 | Stable Disease (SD) | 10 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 3 | Stable Disease (SD) | 2 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 4 | Stable Disease (SD) | 4 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 1 | Progressive disease (PD) | 4 | Participants | |
| Best Overall Response Rate by 6 Months | Cohort 2 | Progressive disease (PD) | 14 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 9 | |
| Overall Study | STARTED | Cohort 2 | 26 | |
| Overall Study | STARTED | Cohort 3 | 9 | |
| Overall Study | STARTED | Cohort 4 | 10 | |
| Overall Study | COMPLETED | Cohort 1 | 9 | |
| Overall Study | COMPLETED | Cohort 2 | 26 | |
| Overall Study | COMPLETED | Cohort 3 | 9 | |
| Overall Study | COMPLETED | Cohort 4 | 10 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events708
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT increased | Investigations | Cohort 1 | 2 | 9 | |
| other | ALT increased | Investigations | Cohort 2 | 11 | 26 | |
| other | ALT increased | Investigations | Cohort 3 | 1 | 9 | |
| other | ALT increased | Investigations | Cohort 4 | 0 | 10 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 6 | 26 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 3 | 1 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 4 | 2 | 10 | |
| other | Alkaline phosphatase increased | Investigations | Cohort 1 | 1 | 9 | |
| other | Alkaline phosphatase increased | Investigations | Cohort 2 | 8 | 26 |
1 to 10 of 708Source ClinicalTrials.gov
See all 708 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 7 | 9 |
| Total, all-cause mortality | Cohort 2 | 20 | 26 |
| Total, all-cause mortality | Cohort 3 | 6 | 9 |
| Total, all-cause mortality | Cohort 4 | 8 | 10 |
| Total, other adverse events | Cohort 1 | 9 | 9 |
| Total, other adverse events | Cohort 2 | 24 | 26 |
| Total, other adverse events | Cohort 3 | 8 | 9 |
| Total, other adverse events | Cohort 4 | 10 | 10 |
| Total, serious adverse events | Cohort 1 | 5 | 9 |
| Total, serious adverse events | Cohort 2 | 7 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA186688 | Texas EXperimental Cancer Therapeutics Network - TEX CTN | MERIC-BERNSTAM, FUNDA; SARANTOPOULOS, JOHN; YAO, JAMES C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03872427
GET https://conductscience.org/api/trials/v1/NCT03872427/events?page=2