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A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

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

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02978235
Study type Interventional
Source Taiho Oncology, Inc.
Contact
Status Terminated
Phase Phase 1
Start date March 1, 2017
Completion date February 1, 2018
View Details
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