Telaglenastat for Malignant Neoplasms
Phase-Based Progress Estimates
Effectiveness
Safety
Washington University School of Medicine, Saint Louis, MO
Malignant Neoplasms+4 More
Telaglenastat - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
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.
Eligible Conditions
- Advanced Cervical Carcinoma
- Malignant Neoplasms
- Cervix Cancer
- Cervical Cancers
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: From completion of chemoradiation through 24 months
Month 24
Distant metastasis-free survival (DMFS)
Local recurrence-free survival (LRFS)
Overall survival (OS)
Progression-free survival (PFS) - experimental arm only
At 3 month post-chemoradiation
Objective response rate (ORR)
Month 24
Late toxicity as measured by number of late adverse events experienced by participant - experimental arm only
Day 90
Acute toxicity as measured by number of acute adverse events experienced by participant - experimental arm only
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Control Arm: Standard of Care Chemoradiation
1 of 2
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
1 of 2
Active Control
Experimental Treatment
42 Total Participants · 2 Treatment Groups
Primary Treatment: Telaglenastat · No Placebo Group · Phase 2
Experimental Arm #1: Telaglenastat + Standard of Care ChemoradiationExperimental Group · 3 Interventions: Telaglenastat, Cisplatin, Radiation treatment · Intervention Types: Drug, Drug, Radiation
Control Arm: Standard of Care ChemoradiationActiveComparator Group · 2 Interventions: Cisplatin, Radiation treatment · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telaglenastat
2020
Completed Phase 1
~30
Cisplatin
2013
Completed Phase 3
~3340
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from completion of chemoradiation through 24 months
Closest Location: Washington University School of Medicine · Saint Louis, MO
2004First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
1465 CompletedClinical Trials
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,293,745 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,772 Previous Clinical Trials
2,269,686 Total Patients Enrolled
Calithera Biosciences, IncIndustry Sponsor
20 Previous Clinical Trials
1,595 Total Patients Enrolled
Julie K Schwarz, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are eligible for definitive chemoradiotherapy, including brachytherapy.
You have histologically confirmed advanced cervical cancer (squamous, adenosquamous, adenocarcinoma or poorly differentiated)
You have a performance status of 0, 1, or 2.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments