Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age ≥ 18 years.
Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous, adenosquamous, adenocarcinoma or poorly differentiated); Federation of Gynecology and Obstetrics (FIGO) 2018 clinical stages III-IVA.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Absolute neutrophil count ≥ 1,500/mcL.
Disqualifiers
Patient has another concurrent active invasive malignancy.
Patient has received prior radiation therapy to the pelvis or previous therapy of any kind for this malignancy, or pelvic radiation for any prior malignancy.
Patient is receiving another investigational agent for the treatment of cancer.
Poorly controlled diabetes, with inability to perform 18F-FDG PET scan.
Trial design
Design model
Parallel
Treatments tested in this trial
Telaglenastat
Drug-800 mg twice per day by mouth
Radiation treatment
Radiation* Standard of care * External beam radiation therapy delivered daily 4 days a week and 1 day per week of brachytherapy.
Cisplatin
Drug* Standard of care * Weekly administration of cisplain
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Control Arm: Standard of Care ChemoradiationActive comparator 2 interventions
Group B: Experimental Arm #1: Telaglenastat + Standard of Care ChemoradiationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 days2
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 chemoradiation3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Calithera Biosciences, Inc
Collaborator
Source ClinicalTrials.gov
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