The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
Background and Rationale:
• TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.
Phase 1:
Primary:
To investigate the safety and tolerability of TAS4464 To identify a tolerated dose of TAS4464
Secondary:
To investigate the preliminary efficacy of TAS4464 To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464 To investigate the pharmacodynamics of TAS4464
Provide written informed consent Women of child-bearing potential must have a negative pregnancy test
Multiple Myeloma:
Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.
Lymphoma:
Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.
Exclusion Criteria:
Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
Major surgery within 28 days Radiation/chemotherapy within 21 days Monoclonal antibodies within 28 days Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days Proteasome inhibitors within 14 days Immunomodulatory agents within 7 days Stem cell transplant within 3 months Current immunosuppressive treatment for graft versus host disease Current use of an investigational agent Active graft versus host disease Known serious illness or medical condition Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class Pregnant or breast-feeding female
