Glutaminase Inhibitor + Chemoradiation for Cervical Cancer

Recruiting in Palo Alto (17 mi)

Julie K. Schwarz, MD, PhD | Department ...

Overseen byJulie Schwarz, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 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.

Inclusion Criteria

Alkaline phosphatase ≤ 2.5 x ULN

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransfersase (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x ULN

Ability to understand and the willingness to sign a written informed consent document

+14 more

Exclusion Criteria

Patient is receiving another investigational agent for the treatment of cancer

Mean resting QTc > 470 msec obtained by electrocardiogram (ECG)

My diabetes is not well-managed, making me unable to undergo a PET scan.

+5 more

Participant Groups

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.

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: