Trials / Completed
CompletedNCT03047993
Glutaminase Inhibitor CB-839 and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndrome
Phase Ib/II Study of the Glutaminase Inhibitor CB-839 in Combination With Azacitidine in Patients With Advanced Myelodysplastic Syndrome
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I/II trial studies the side effects of glutaminase inhibitor CB-839 in combination with azacitidine in treating patients with myelodysplastic syndrome that has spread to other places in the body. Glutaminase inhibitor CB-839 and azacitidine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES: I. To determine the safety, tolerability and clinical activity of glutaminase inhibitor CB-839 (CB-839) in combination with azacitidine (AZA) for patients with advanced myelodysplastic syndrome (MDS). SECONDARY OBJECTIVES: I. To explore the pharmacokinetics (PK) of CB-839 in combination with AZA. II. To explore the pharmacodynamics (PDn) of CB-839 in combination with AZA. III. To assess overall survival, event-free survival and duration of response of CB-839 in combination with AZA. OUTLINE: Patients receive glutaminase inhibitor CB-839 orally (PO) twice daily (BID) on days 1-28 and azacitidine subcutaneously (SC) or intravenously (IV) over 10-40 minutes on days 1-7. After completion of study treatment, patients are followed up at 28 days.
Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia
- Blasts 20-30 Percent of Bone Marrow Nucleated Cells
- Blasts 20-30 Percent of Peripheral Blood White Cells
- Chronic Myelomonocytic Leukemia
- High Risk Myelodysplastic Syndrome
- IPSS Risk Category Intermediate-2
- Myelodysplastic Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Azacitidine | Given IV or SC |
| DRUG | Glutaminase Inhibitor CB-839 | Given PO |
Timeline
- Start date
- 2017-11-15
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
- First posted
- 2017-02-09
- Last updated
- 2024-05-14
- Results posted
- 2024-05-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03047993. Inclusion in this directory is not an endorsement.