Multiple Myeloma Clinical Trial
Official title:
A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.
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 ;
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