Telaglenastat for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MO
Malignant Neoplasms+4 More
Telaglenastat - Drug
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

1 of 3

Other trials for Malignant Neoplasms

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

2 of 3
This is further along than 68% of similar trials

Other trials for Malignant Neoplasms

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
Photo of washington university school of medicine 1Photo of washington university school of medicine 2Photo of washington university school of medicine 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.