NCT02978235

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

A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Multiple Myeloma
• NonHodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	TAS4464	Intravenous (IV) Infusion

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-11-30
• Last updated: 2024-09-05

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study