Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
-800 mg twice per day by mouth
* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
* Standard of care * Weekly administration of cisplain
Washington University School of Medicine
St Louis, Missouri, United States
Progression-free survival (PFS) - experimental arm only
* PFS is defined as the duration of time from start of telaglenastat to time of progression or death, whichever occurs first. * Progressive disease: New foci of abnormal FDG uptake not present on the pretreatment FDG-PET study
Time frame: Through completion of follow-up (estimated to be 24 months and 9 weeks)
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Acute toxicity is defined as any toxicity occurring within 90 days from first receiving study radiotherapy or death, whatever event is observed first.
Time frame: From start of chemoradiation treatment through 90 days
Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only
* Toxicity evaluation will report events according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE) * Late toxicities include any toxicity that is determined possibly, probably, or definitely related to treatment, within 24 months after completion of treatment.
Time frame: From day 91 through 24 months after completion of chemoradiation
Overall survival (OS)
-OS is defined as the days from the start of Telaglenastat treatment to the date of death, censored at the last follow-up otherwise.
Time frame: Through completion of follow-up (estimated to be 24 months and 9 weeks)
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