Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors

Launched by CALITHERA BIOSCIENCES, INC · Feb 24, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• • Disease-Specific Inclusion Criteria
• Patients must have one of the following diseases that is either relapsed or refractory to 2 or more prior treatments:
• • NHL: At least one measurable lesion
• • WM: Measurable IgM, with a minimum level of ≥ 2x ULN
• • MM: Serum M-protein ≥ 0.5 g/dL and/or urine M-protein ≥ 200 mg/24 hr. In Part 2, disease that is considered measurable per the IMWG criteria
• • Other Inclusion Criteria
• • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• • Life Expectancy of at least 3 months
• • Adequate hepatic, renal, cardiac and hematological function
• • Exclusion Criteria
• • Any other current malignancy
• • Treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug
• • Recent bone marrow transplant
• • Unable to receive medications by mouth
• • Major surgery within 28 days before the first dose of study drug
• • Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation
• • Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drug
• • Refractory nausea and vomiting or other situation that may preclude adequate absorption
• • Other conditions that could interfere with treatment