A Phase 1/2, Open-Label Safety, Pharmacokinetic And Efficacy Study Of TAS4464 In Patients With Multiple Myeloma Or Lymphoma

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Overview

This is a first-in-human clinical research trial of TAS4464, which is an investigational drug. This means that TAS4464 has not been approved for use in the US in patients with Multiple Myeloma, except in a clinical research trial. TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, which means that TAS4464 is a drug that acts against a specific protein in the body (NAE) involved in helping cancer cells live and grow.

The purpose of the Phase 1 portion of the study is to find out how TAS4464 is tolerated, what side effects occur, whether it has an effect on Multiple Myeloma, and to find the right dose to be used in the Phase 2 portions of the study. In addition, the Phase 1 part of the study will look at pharmacokinetics (how much TAS4464 gets into the bloodstream and how long it stays there), pharmacodynamics (whether the study drug is affecting the protein it acts against), and pharmacogenomics (testing to show how genes affect how the study drug is handled by the body).

The purpose of the Phase 2 portions of the trial will be to continue studying the safety and effectiveness of TAS4464 in Multiple Myeloma at the doses identified during Phase 1.

This is an open-label trial, which means that both you and your trial doctor will know the trial drug and dose you are receiving.

SparkCures ID 867
Trial Phase Phase 1/2
Enrollment 243 Patients
Treatments
  • TAS4464
Trial Sponsors
  • Taiho Oncology, Inc.
NCT Identifier

NCT02978235

CLOSED

This trial has terminated.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Provide written informed consent
  2. Women of child-bearing potential must have a negative pregnancy test
  3. Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.
  4. Have received prior treatment with daratumumab (Darzalex®) a proteasome inhibitor and an immunomodulating agent.
  5. Adequate hematologic and organ function as defined by the following criteria within 14 days prior to Cycle 1 Day 1: 
    • Hemoglobin ≥ 8.0 g/dL, excluding measurements within 7 days of a transfusion of packed red blood cells (RBCs) or whole blood. 
    • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim. 
    • Platelet count ≥ 75 × 109/L; excluding measurements obtained within 3 days after transfusion of platelets. A platelet count of ≥ 50 × 109/L is allowed if the % plasma cells in the bone marrow is > 50%.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); 
    • Total serum bilirubin ≤ 1.5 × ULN, including in the case of Gilbert’s disease 
    • Serum creatinine ≤ 1.5 x ULN or Creatinine clearance (CrCl) ≥ 40 mL/min; the CrCl can be measured or calculated from serum creatinine (Cockcroft-Gault Equation)

Exclusion Criteria:

  1. Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
    • Major surgery within 28 days
    • Radiation/chemotherapy within 21 days (except limited field radiation)
    • Monoclonal antibodies within 28 days
    • Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
    • Proteasome inhibitors within 14 days
    • Immunomodulatory agents within 7 days
    • Stem cell transplant within 3 months
    • Current immunosuppressive treatment for graft versus host disease
    • Current use of an investigational agent
  2. Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
  3. Pregnant or breast-feeding female

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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