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

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ClinicalTrials.gov Identifier: NCT02978235
Recruitment Status : Terminated (Business Decision)
First Posted : November 30, 2016
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Multiple Myeloma NonHodgkin Lymphoma Drug: TAS4464 Phase 1 Phase 2

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : March 6, 2018


Arm Intervention/treatment
Experimental: TAS4464 Drug: TAS4464
Intravenous (IV) Infusion



Primary Outcome Measures :
  1. 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) ]
  2. 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 ]


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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

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


Locations
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
John Theurer Cancer Center at Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Study Director: Robert Winkler, MD Sponsor Medical Monitor

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02978235     History of Changes
Other Study ID Numbers: TAS-4464-101
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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