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 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Intravenous (IV) Infusion
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
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
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John Theurer Cancer Center at Hackensack Meridian Health
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States