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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.
Verified October 2017 by Taiho Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02978235
First Posted: November 30, 2016
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Taiho Oncology, Inc.
  Purpose
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:

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.

Lymphoma:

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978235


Contacts
Contact: Robert Winkler, MD 609-750-5300 rwinkler@taihooncology.com

Locations
United States, Maryland
Center for Cancer and Blood Disorders Recruiting
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Weisberg Cancer Treatment Center Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
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.
Investigators
Study Director: Robert Winkler, MD Sponsor Medical Monitor
  More Information

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02978235     History of Changes
Other Study ID Numbers: TAS-4464-101
First Submitted: November 21, 2016
First Posted: November 30, 2016
Last Update Posted: October 3, 2017
Last Verified: October 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.:
TAS4464
Multiple Myeloma
Relapsed/Refractory
Lymphoma
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
DLBCL
Mantle Cell Lymphoma
MCL
Peripheral T-Cell Lymphoma
PTCL
NEDD8
NAE inhibitor
Neoplasms
Hematologic Diseases
Myeloma

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