Non Hodgkin Lymphoma Clinical Trial
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
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.
Full Description
The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
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
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent
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:
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
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
Active graft versus host disease
Known serious illness or medical condition
Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
Pregnant or breast-feeding female
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There are 7 Locations for this study
Bethesda Maryland, 20817, United States
Boston Massachusetts, 02215, United States
Farmington Hills Michigan, 48334, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
New York New York, 10029, United States
Canton Ohio, 44718, United States
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