Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

August 20, 2014

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:
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:
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

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