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

2016-12-01 16:08:21 | BioPortfolio

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. The Phase 2 portion of the study will investigate the efficacy and safety of TAS4464 in patients with Multiple Myeloma or Lymphoma

Description

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

Phase 2:

Primary:

• To investigate the efficacy of TAS4464

Secondary:

• To further investigate the safety profile of TAS4464

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

TAS4464, Intravenous (IV) Infusion

Location

Boston
Massachusetts
United States

Status

Not yet recruiting

Source

Taiho Oncology, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:21-0500

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