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Enzyme Inhibitor

Telaglenastat for Cancer

Phase 2

Waitlist Available

Led By Vivek Subbiah

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically confirmed malignancy that is metastatic or unresectable

Patient must have histopathologic confirmation of advanced solid tumor with specific mutations (NF1, KEAP1/NRF2, STK11/LKB1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time to progression starting at c1d1, assessed up to 2 years from treatment start date

Awards & highlights

Study Summary

This trial is testing how well telaglenastat hydrochloride, a drug that inhibits the growth of cells, works in treating patients with metastatic or unresectable solid tumors that have certain genetic mutations.

Who is the study for?

Adults with advanced solid tumors or malignant peripheral nerve sheath tumors that can't be removed by surgery or have spread, and specific genetic mutations (NF1, KEAP1/NRF2, STK11/LKB1). Must meet certain health criteria, agree to contraception if applicable, and have no standard treatment options left. Cannot join if pregnant/breastfeeding, recently had cancer treatments, uncontrolled illnesses, allergic to similar compounds as the drug being tested.Check my eligibility

What is being tested?

The trial is testing Telaglenastat Hydrochloride's effectiveness on patients with specific gene mutations in their tumors. This drug aims to block an enzyme needed for tumor cell growth which may halt the progression of cancer. The study includes imaging tests like CT and PET scans and biospecimen collection to monitor responses.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to blocking enzymes necessary for cell growth such as fatigue, nausea, liver issues or changes in blood counts due to disruption of normal cellular functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread and cannot be removed with surgery.

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My advanced solid tumor has specific genetic changes.

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I have no standard treatments left to try.

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I am older than 18 years.

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My cancer can be measured and biopsied according to standard criteria.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time to progression starting at c1d1, assessed up to 2 years from treatment start date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time to progression starting at c1d1, assessed up to 2 years from treatment start date

This trial's timeline: 3 weeks for screening, Varies for treatment, and time to progression starting at c1d1, assessed up to 2 years from treatment start date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best overall response rate

Secondary outcome measures

Clinical benefit rate

Incidence of adverse events

Overall response rate

+3 more

Other outcome measures

PD tumor oncometabolite levels of aspartate

PD tumor oncometabolite levels of glutamate

Pharmacodynamic (PD) tumor oncometabolite levels of glutamine

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (telaglenastat hydrochloride)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,045 Total Patients Enrolled

Vivek SubbiahPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

4 Previous Clinical Trials

231 Total Patients Enrolled

Funda Meric-BernstamPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

6 Previous Clinical Trials

12,710 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined this clinical experiment?

"At present, this trial is not recruiting any new patients. It was initially posted on August 26th 2019 and its last update happened in September 1st 2022. For those searching for other trials, there are currently 2408 studies actively accepting enrolment for perineurioma and 7 distinct Pharmacodynamic Studies looking for participants."

Answered by AI

Is recruitment for the trial still open?

"Clinicaltrials.gov indicates that this research study, initially posted on August 26th 2019, is not currently recruiting patients. Nevertheless, there are still 2415 other clinical trials accepting participants at the moment."

Answered by AI

What is the geographical spread of this research endeavor?

"Eligible patients can join this medical trial at Olathe Health Cancer Center in Kansas, Salina Regional Health Center in Florida and UM Sylvester Comprehensive Cancer Center at Kendall in North carolina. There are also 31 other sites where participation is possible."

Answered by AI

Has the Pharmacodynamic Study been accepted by the FDA?

"Pharmacodynamic Study was given a safety rating of 2 based on the Phase 2 nature of the trial, indicating some evidence for its security but none for efficacy."

Answered by AI

Have preceding trials explored the pharmacodynamic properties of this drug?

"Currently there are 7 studies in progress researching Pharmacodynamic Study. None of them have reached Phase 3 yet. Most trials take place in Plantation, Florida although other sites across the country host research as well; a total of 76 medical centres are involved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03872427.