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Anti-metabolite

Glutaminase Inhibitor CB-839 for Myelodysplastic Syndrome

Phase 1 & 2
Waitlist Available
Led By Courtney DiNardo
Research Sponsored by M.D. Anderson Cancer Center
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 up to 4 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat myelodysplastic syndrome, to see if it is more effective than the current standard of care, and to assess side effects.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Aplastic Anemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events Common Toxicity Criteria version 4.0
Secondary outcome measures
Anti-tumor activity
Drug exposure levels
Duration of response
+5 more

Side effects data

From 2023 Phase 1 trial • 48 Patients • NCT02038777
100%
Leukopenia
100%
Thrombocytopenia
83%
Dysgeusia
83%
Neutropenia
67%
Anaemia
67%
Febrile neutropenia
67%
Nausea
67%
Decreased appetite
50%
Pyrexia
50%
Rash
50%
Vomiting
50%
Weight decreased
50%
Hypokalaemia
50%
Hypophosphataemia
50%
Alopecia
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Blood creatinine increased
33%
Constipation
33%
Malaise
33%
Hypoalbuminaemia
33%
Stomatitis
33%
Hyperkalaemia
33%
Hypomagnesaemia
33%
Hyponatraemia
33%
Insomnia
17%
Dry skin
17%
Periodontitis
17%
Erythema nodosum
17%
Pain in extremity
17%
Fibrin D dimer increased
17%
Delirium
17%
Disseminated intravascular coagulation
17%
Gingival bleeding
17%
Oedema peripheral
17%
Hepatic function abnormal
17%
Blood alkaline phosphatase increased
17%
Hypercalcaemia
17%
Hypocalcaemia
17%
Back pain
17%
Acute lung injury
17%
Pneumothorax
17%
Contusion
17%
Blood bilirubin increased
17%
Pneumonia bacterial
17%
Pneumonia cytomegaloviral
17%
Interstitial lung disease
17%
Dermatitis exfoliative generalised
17%
Lymphopenia
17%
Cardiac failure congestive
17%
Diarrhoea
17%
Catheter site pain
17%
Facial bones fracture
17%
Fall
17%
Blood creatine phosphokinase increased
17%
Electrocardiogram QT prolonged
17%
Fibrin degradation products increased
17%
Arthralgia
17%
Muscle spasms
17%
Tendonitis
17%
Headache
17%
Glycosuria
17%
Haematuria
17%
Proteinuria
17%
Oropharyngeal pain
17%
Pneumonitis
17%
Rash maculo-papular
17%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin
Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg
Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg
Monotherapy Cohort: PF-04449913 25 mg
Monotherapy Cohort: PF-04449913 100 mg
Monotherapy Cohort: PF-04449913 50 mg
Combination Cohort 3: PF-04449913 100 mg + Azacitidine
Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (glutaminase inhibitor CB-839, azacitidine)Experimental Treatment2 Interventions
Patients receive glutaminase inhibitor CB-839 PO BID on days 1-28 and azacitidine SC or IV over 10-40 minutes on days 1-7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Glutaminase Inhibitor CB-839
2017
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,420 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,617 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
680 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Glutaminase Inhibitor CB-839 a new medication?

"There are 185 clinical trials investigating Glutaminase Inhibitor CB-839 with 33 of those in Phase 3. Most of these clinical trials for Glutaminase Inhibitor CB-839 are based in Saint Louis, Missouri; however, there are 5786 locations running clinical trials for Glutaminase Inhibitor CB-839 globally."

Answered by AI

For what purpose is Glutaminase Inhibitor CB-839 most commonly prescribed?

"Glutaminase Inhibitor CB-839 has shown to be an effective treatment for patients with malignant neoplasms, 20-30% blasts, and neutropenia and/or thrombocytopenia."

Answered by AI

Is it still possible to sign up for this experiment?

"Unfortunately, this specific trial is not searching for any more patients at the moment. Although, it's good to know that there are over 3000 other trials currently underway that might be a better fit."

Answered by AI

What is the total sample size for this research project?

"This study has already completed patient recruitment. The trial was advertised from November 15th, 2017 to September 22nd, 2022. However, there are still other medical trials open for patients suffering from myelodysplastic syndromes and Glutaminase Inhibitor CB-839."

Answered by AI
~4 spots leftby Mar 2025