Primary Outcome Measure:
- Safety and tolerability of CB-839: Incidence of adverse events [ Time Frame: Every 21 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood [ Time Frame: Study Days 1, 15, and 22 ] [ Designated as safety issue: No ]
- Pharmacodynamics: % inhibition of glutaminase in blood [ Time Frame: Study Days 1 and 15 ] [ Designated as safety issue: No ]
- Clinical activity: Change in tumor volume from baseline [ Time Frame: Every 9 weeks until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ] [ Designated as safety issue: No ]
Eligibility Criteria
- Inclusion Criteria:
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- Advanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. Newly diagnosed patients who refuse standard treatment regimens are also eligible
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Life Expectancy of at least 3 months
- Adequate hepatic, renal, cardiac, and hematologic function
- Measurable disease by RECIST criteria
- Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
- Exclusion Criteria:
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- Any other current or previous malignancy
- Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days
- Unable to receive medications oral medications
- Major surgery within 28 days before Cycle 1 Day 1
- Active infection requiring within 2 weeks prior to first dose of study drug
- Patients who are known to have HIV, Hepatitis A, B or C or CMV reactivation
- Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose of study drug
- Conditions that could interfere with treatment or protocol-related procedures
