Telaglenastat for Cancer

Recruiting at 34 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Chemotherapy, Radiotherapy, Glioma, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you should be cautious if you are taking medications that interact with CYP2C9, as telaglenastat may affect them. It's important to discuss your current medications with the trial team to understand any potential interactions.

What safety data exists for Telaglenastat in humans?

The research articles provided do not contain specific safety data for Telaglenastat or Telaglenastat Hydrochloride in humans. ^{1 2 3 4 5}

Research Team

Funda Meric-Bernstam

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

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.

Inclusion Criteria

My cancer has spread and cannot be removed with surgery.

I am older than 18 years.

I weigh at least 40 kg.

Exclusion Criteria

I have or had hepatitis B or C.

I am taking medications that affect my liver enzyme levels without being cautious.

Pregnant or breastfeeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive telaglenastat hydrochloride orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6 months

Monthly visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months

Quarterly visits (in-person)

Treatment Details

Interventions

• Telaglenastat Hydrochloride

Trial Overview 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.

Participant Groups

Group I: Treatment (telaglenastat hydrochloride) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

A new standardized Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) subset was developed specifically for monitoring adverse events in prostate cancer patients, based on input from 30 patients and 16 healthcare providers.

The final subset includes 12 key adverse events such as erectile dysfunction, urinary issues, and emotional distress, with 90% consensus among participants, highlighting the importance of capturing patient experiences for better care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure. Feldman, E., Pos, FJ., Smeenk, RJ., et al.[2023]

In a study involving 604 breast cancer patients undergoing chemotherapy, self-reported treatment-related side effects (TSEs) showed significantly longer durations compared to doctor-reported durations, highlighting the importance of patient perspectives in assessing side effects.

The findings suggest that doctors often underestimate the incidence and duration of TSEs, indicating that incorporating patient-reported outcomes into clinical practice could provide a more accurate understanding of the total burden of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. Galizia, D., Milani, A., Geuna, E., et al.[2021]

References

1. France pubmed.ncbi.nlm.nih.gov

Dermatological adverse drug reactions of anticancer drugs: International data of pharmacovigilance: VigiBase®. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

[Description of adverse events in publications of clinical trials: much room for improvement.] [2020]

3. England pubmed.ncbi.nlm.nih.gov

Selecting a PRO-CTCAE-based subset for patient-reported symptom monitoring in prostate cancer patients: a modified Delphi procedure. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Influence of Supportive Oncodermatology Interventions on Patient Quality of Life: A Cross-Sectional Survey. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Self-evaluation of duration of adjuvant chemotherapy side effects in breast cancer patients: A prospective study. [2021]