Trial Title:
Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
NCT ID:
NCT05521997
Condition:
Advanced Cervical Carcinoma
Cervical Cancer
Cervix Cancer
Cancer of the Cervix
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
Conditions: Keywords:
advanced cervical cancer
Glutaminase Inhibitor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomization will occur on a 5:1 basis to experimental arm and control arm. The first 5
participants randomized to the experimental arm will be considered the safety lead-in.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Telaglenastat
Description:
-800 mg twice per day by mouth
Arm group label:
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
Other name:
CB-893
Intervention type:
Radiation
Intervention name:
Radiation treatment
Description:
- Standard of care
- External beam radiation therapy delivered daily 4 days a week and 1 day per week of
brachytherapy.
Arm group label:
Control Arm: Standard of Care Chemoradiation
Arm group label:
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
- Standard of care
- Weekly administration of cisplain
Arm group label:
Control Arm: Standard of Care Chemoradiation
Arm group label:
Experimental Arm #1: Telaglenastat + Standard of Care Chemoradiation
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients eligible for definitive chemoradiotherapy, including brachytherapy
- Patient age ≥ 18 years.
- Patients with histologically confirmed newly diagnosed advanced cervical cancer
(squamous, adenosquamous, adenocarcinoma or poorly differentiated); Federation of
Gynecology and Obstetrics (FIGO) 2018 clinical stages III-IVA.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Absolute neutrophil count ≥ 1,500/mcL.
- Platelets ≥ 100,000/mcL.
- Hemoglobin ≥ 8 g/dL (can be transfused prior to study).
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); patients with
known Gilbert disease with serum bilirubin ≤ 3 x ULN may be enrolled.
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT]/alanine aminotransfersase (ALT) (serum glutamate pyruvate transaminase [SGPT]
≤ 2.5 x ULN.
- Alkaline phosphatase ≤ 2.5 x ULN.
- Serum creatinine ≤ 1.5 mg/dL to receive weekly cisplatin; patients whose serum
creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if there is no
hydronephrosis and the estimated creatinine clearance (CCr) is ≥ 30 ml/min. For the
purpose of estimating the CCr, formulas, including Cockcroft and Gault for females
or similar, should be used.
- International normalize ratio (INR) and activated partial thromboplastin time (aPTT)
≤ 1.5 x ULN (this applies only to patients who do not receive therapeutic
anticoagulation; patients receiving therapeutic anticoagulation, such as
low-molecular weight heparin or warfarin, should be on a stable dose).
- Patient does not have uncontrolled diabetes mellitus (i.e. fasting blood glucose
>200 mg/dL).
- Patient does not have a known allergy to cisplatin or compounds of similar biologic
composition as CB-839.
- Patient is not actively breastfeeding (or has agreed to discontinue before the
initiation of protocol therapy).
- Ability to understand and the willingness to sign a written informed consent
document.
- Patients does not have known human immunodeficiency virus syndrome (HIV testing
optional).
Exclusion Criteria:
- Patient has another concurrent active invasive malignancy.
- Patient has received prior radiation therapy to the pelvis or previous therapy of
any kind for this malignancy, or pelvic radiation for any prior malignancy.
- Patient is receiving another investigational agent for the treatment of cancer.
- Poorly controlled diabetes, with inability to perform 18F-FDG PET scan.
- Patient is pregnant or breastfeeding.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements.
- Mean resting QTc > 470 msec obtained by electrocardiogram (ECG).
- Severe, active co-morbidity defined as follows:
- Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel
obstruction
- Patients who require parental hydration and/or nutrition
- Patients who require drainage gastrostomy tube
- Evidence of bleeding diathesis or clinically significant coagulopathy
- Serious, non-healing or dehiscing wound, active ulcer or untreated bone
fracture
- History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within
1 month of study enrollment
- Significant cardiovascular or cerebrovascular disease including: Uncontrolled
hypertension (systolic blood pressure [SBP] >= 150; diastolic blood pressure
[DBP] >= 90)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Contact:
Last name:
Julie K Schwarz, M.D., Ph.D.
Phone:
314-608-6813
Email:
jschwarz@wustl.edu
Investigator:
Last name:
Julie K Schwarz, M.D., Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Stephanie Markovina, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Andrea Hagemann, M.D., MSCI
Email:
Sub-Investigator
Investigator:
Last name:
Dineo Khabele, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Lindsay Kuroki, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
L. Stewart Massad, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Carolyn McCourt, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Maggie Mullen, M.S.
Email:
Sub-Investigator
Investigator:
Last name:
David Mutch, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Powell, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Premal Thaker, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
David DeNardo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Gary Patti, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Li Ding, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Esther Lu, Ph.D.
Email:
Sub-Investigator
Start date:
October 31, 2024
Completion date:
January 7, 2031
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Calithera Biosciences, Inc
Agency class:
Industry
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05521997
http://www.siteman.wustl.edu
