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Alkylating agents

Glutaminase Inhibitor + Chemoradiation for Cervical Cancer

Phase 2
Waitlist Available
Led By Julie K Schwarz, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 24 months and 9 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial found that adding the drug telaglenastat to standard chemotherapy and radiation treatments for cervical cancer improved progression-free survival compared to historical rates.

Who is the study for?
This trial is for adults over 18 with newly diagnosed advanced cervical cancer (stages III-IVA). They must have a certain level of blood cells, liver and kidney function, not be breastfeeding, and able to consent. Excluded are those with severe illnesses, prior treatments for this cancer or pelvic radiation, uncontrolled diabetes or HIV, pregnancy/breastfeeding women, and known allergies to the drugs used.
What is being tested?
The study tests if adding telaglenastat (a glutaminase inhibitor) to standard chemoradiation therapy improves progression-free survival in advanced cervical cancer patients compared to historical data of chemoradiation alone. Participants will receive cisplatin chemotherapy alongside radiation treatment.
What are the potential side effects?
Possible side effects include reactions related to cisplatin like nausea and kidney issues; telaglenastat may cause fatigue or upset stomach; radiation could lead to skin irritation or fatigue. Each patient's experience can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 24 months and 9 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 24 months and 9 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) - experimental arm only
Secondary study objectives
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only
Overall survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm #1: Telaglenastat + Standard of Care ChemoradiationExperimental Treatment3 Interventions
-Participants will receive 2 weeks of telaglenastat and 7 weeks of standard of care chemoradiation plus telaglenastat.
Group II: Control Arm: Standard of Care ChemoradiationActive Control2 Interventions
-Participants will receive 7 weeks of standard of care chemoradiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telaglenastat
2020
Completed Phase 1
~30
Cisplatin
2013
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,842 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,959 Total Patients Enrolled
Calithera Biosciences, IncIndustry Sponsor
33 Previous Clinical Trials
1,979 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05521997 — Phase 2
Cervical Cancer Research Study Groups: Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation, Control Arm: Standard of Care Chemoradiation
Cervical Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05521997 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521997 — Phase 2
~28 spots leftby Jan 2031
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