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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 24 months and 9 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 24 months and 9 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) - experimental arm only
Secondary outcome measures
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)
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
~1940
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,765 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,031 Total Patients Enrolled
Calithera Biosciences, IncIndustry Sponsor
33 Previous Clinical Trials
1,979 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My diabetes is not well-managed, making me unable to undergo a PET scan.My hemoglobin level is at least 8 g/dL, or I can receive a transfusion to reach this.I can take care of myself and perform daily activities.My kidney function is good enough for cisplatin treatment.My blood clotting tests are within normal limits, or I am on a stable dose of blood thinners.I am not allergic to cisplatin or similar drugs.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I do not have HIV, or I have not been tested for it.I have had radiation therapy to the pelvis or treatment for this cancer before.I have another active cancer besides the one being treated.My cervical cancer is advanced (stage III-IVA) and newly diagnosed.I am a candidate for specific cancer treatment with drugs and radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
- Group 2: Control Arm: Standard of Care Chemoradiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there long-term repercussions to taking Telaglenastat?
"Telaglenastat is still being tested for efficacy in human trials, but it has shown some promise in terms of safety. Our team rates it as a 2."
Answered by AI
How can people sign up for this opportunity?
"The clinical trial in question is no longer recruiting patients, according to the information found on clinicaltrials.gov. This particular study was first posted on 1/31/2023 and last edited 8/26/2022; however, 411 other trials are still looking for participants."
Answered by AI
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