Overview

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

Eligibility

Inclusion Criteria:

• Advanced Non-Small Cell Lung Cancer
• Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy
• Adults over 18 years
• Performance status (Eastern Cooperative Oncology Group) less than or equal to 2
• Life expectancy greater than 2 months
• Laboratory Values:

        Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater
        than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum
        Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per
        minute Hemoglobin A1C less than 7 Normal Thyroid function
          -  No history of hyperthyroidism
          -  Abstinence from alcohol and supplements
          -  Not pregnant, lactating and willing to use birth control throughout study
          -  Able to provide consent
          -  Positive Emission Tomography/Computer Tomography part of subjects care plan at
             baseline
        Exclusion Criteria:
          -  Prior use of Withania somnifera
          -  Phenylketonuria
          -  Inability to swallow capsules
          -  Hypersensitivity to study drug ingredients
          -  Unstable medical or surgical condition
          -  History of additional cardiac risk factors
          -  Requiring drugs that are "strong" inhibitors of cytochrome P450
          -  Requiring irradiation
          -  Requiring intravenous fluids or hyperalimentation
          -  Requiring transfusions, dialysis, or other procedures
          -  Active infection
          -  Human Immunodeficiency Virus
          -  Must exceed washout period of prior treatments
          -  Psychiatric, neurological or other reason that precludes subjects ability to
             participate