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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 Phase 2 portion of the study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma or Lymphoma
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.
- To investigate the safety and tolerability of TAS4464
- To identify a tolerated dose of TAS4464
- To investigate the preliminary efficacy of TAS4464
- To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464
- To investigate the pharmacodynamics of TAS4464
• To investigate the efficacy of TAS4464
• To further investigate the safety profile of TAS4464
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
TAS4464, Intravenous (IV) Infusion
Not yet recruiting
Taiho Oncology, Inc.
Published on BioPortfolio: 2016-12-01T16:08:21-0500
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A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
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Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.
An imidazole antifungal agent that is used topically and by intravenous infusion.