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Trial record 1 of 1 for:    tas4464
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A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Taiho Oncology, Inc.
Information provided by (Responsible Party):
Taiho Oncology, Inc. Identifier:
First received: November 21, 2016
Last updated: August 14, 2017
Last verified: August 2017
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

Condition Intervention Phase
Multiple Myeloma NonHodgkin Lymphoma Drug: TAS4464 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma

Resource links provided by NLM:

Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures [ Time Frame: Completion of Cycle 1 (28 days) ]
  • Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results [ Time Frame: Up to 5 years ]

Estimated Enrollment: 243
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS4464 Drug: TAS4464
Intravenous (IV) Infusion

Detailed 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:


  • 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

Phase 2:


• To investigate the efficacy of TAS4464


• To further investigate the safety profile of TAS4464


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provide written informed consent
  2. Women of child-bearing potential must have a negative pregnancy test

Multiple Myeloma:

Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.


Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.

Exclusion Criteria:

  1. Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:

    1. Major surgery within 28 days
    2. Radiation/chemotherapy within 21 days
    3. Monoclonal antibodies within 28 days
    4. Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
    5. Proteasome inhibitors within 14 days
    6. Immunomodulatory agents within 7 days
    7. Stem cell transplant within 3 months
    8. Current immunosuppressive treatment for graft versus host disease
    9. Current use of an investigational agent
  2. Active graft versus host disease
  3. Known serious illness or medical condition
  4. Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
  5. Pregnant or breast-feeding female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02978235

Contact: Robert Winkler, MD 609-750-5300

United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Michigan
Weisberg Cancer Treatment Center Recruiting
Farmington Hills, Michigan, United States, 48334
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Taiho Oncology, Inc.
Study Director: Robert Winkler, MD Sponsor Medical Monitor
  More Information

Responsible Party: Taiho Oncology, Inc. Identifier: NCT02978235     History of Changes
Other Study ID Numbers: TAS-4464-101
Study First Received: November 21, 2016
Last Updated: August 14, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taiho Oncology, Inc.:
Multiple Myeloma
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Peripheral T-Cell Lymphoma
NAE inhibitor
Hematologic Diseases

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders processed this record on September 21, 2017